Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations

May 19, 2026 updated by: SWOG Cancer Research Network

Randomized Phase III Study of Second-Line Chemotherapy With or Without Panitumumab for KRAS Wild Type, Locally Advanced or Metastatic Pancreatic Adenocarcinoma

This phase III trial compares the effect of adding panitumumab to standard chemotherapy (with nanoliposomal Irinotecan, leucovorin, and 5-fluorouracil [5-FU] or irinotecan, leucovorin, and 5-FU or nab-paclitaxel and gemcitabine) versus standard chemotherapy alone in treating patients with KRAS wild type (WT) pancreatic ductal adenocarcinoma that cannot be removed by sugery (unresectable) or that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Panitumumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Chemotherapy drugs, such as nanoliposomal irinotecan, leucovorin, 5-FU, irinotecan, nab-paclitaxel and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding panitumumab to standard chemotherapy may be effective in treating patients with unresectable, locally advanced, or metastatic KRAS WT pancreatic ductal adenocarcinoma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

PRIMARY OBJECTIVE:

I. To compare overall survival (OS) between participants with locally advanced or metastatic KRAS wild type (WT) pancreatic ductal adenocarcinoma (PDA) randomized to panitumumab plus second-line cytotoxic chemotherapy (5FU- or gemcitabine-based) versus chemotherapy alone.

SECONDARY OBJECTIVES:

I. To compare progression-free survival (PFS) between treatment arms. II. To compare the overall response rate (ORR) (ORR, including confirmed and unconfirmed, complete and partial response according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria) between treatment arms in participants with measurable disease.

III. To compare disease control rate (DCR) (DCR, defined as ORR + stable disease rate [SD]) between treatment arms in participants with measurable disease.

IV. To evaluate the frequency and severity of toxicity within each treatment arm.

V. To compare duration of response (DoR) between treatment arms in participants with measurable disease.

ADDITIONAL OBJECTIVES:

I. To compare OS and PFS between treatment arms in the subgroup of participants with MAPK negative cancers, that is, cancers without any known mitogen-activated protein kinase (MAPK) pathway molecular alterations (type 1 or 2 BRAF mutations; BRAF, NRG1, ROS1, FGFR1-3 and RAF1 fusions; EGFR, KRAS, and FGFR1-3 amplification).

II. To compare ORR in participants with MAPK negative cancers between treatment arms in participants with measurable disease.

PATIENT-REPORTED OUTCOMES COMMON TERMINOLOGY CRITIERIA FOR ADVERSE EVENTS (CTCAE) OBJECTIVES:

I. To compare health-related quality of life (QOL) by treatment arm at 8 weeks after randomization, measured by the Functional Assessment of Cancer Therapy - General (FACT-G) total score.

II. To compare the impact of treatment toxicity by treatment arm at 8 weeks after randomization, measured by the Functional Assessment of Chronic Illness Therapy (FACIT) Item GP5.

III. To compare changes from baseline in QOL and impact of treatment toxicity between treatment arms using FACT-G total score and FACIT Item GP5 to 24 weeks after randomization.

IV. To assess patient-reported symptoms by treatment arm using selected patient reported outcome (PRO)-CTCAE items including gastrointestinal, dermatologic, and constitutional symptoms of pain and fatigue.

BANKING OBJECTIVE:

I. To bank specimens for future correlative studies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive panitumumab intravenously (IV) over 30-90 minutes on days 1 and 15. Patients also receive either nanoliposomal irinotecan IV over 90 minutes on days 1 and 15, leucovorin IV over 30 minutes on days 1 and 15, and 5-FU IV over 46 hours on days 1-3 and 15-17 or irinotecan IV over 90 minutes, leucovorin IV over 90-120 minutes on days 1 and 15, 5-FU IV bolus over 5-15 minutes on days 1 and 15 and 5FU IV continuous over 46 hours on days 1-3 and 15-17 or nab-paclitaxel IV over 30 minutes, and gemcitabine IV over 30 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan and blood sample collection throughout the study.

ARM B: Patients receive either nanoliposomal irinotecan IV over 90 minutes on days 1 and 15, leucovorin IV over 30 minutes on days 1 and 15, and 5-FU IV over 46 hours on days 1-3 and 15-17 or irinotecan IV over 90 minutes, leucovorin IV over 90-120 minutes on days 1 and 15, 5-FU IV bolus over 5-15 minutes on days 1 and 15 and 5FU IV continuous over 46 hours on days 1-3 and 15-17 or nab-paclitaxel IV over 30 minutes, and gemcitabine IV over 30 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and blood sample collection throughout the study.

After completion of study treatment, patients are followed up for up to 3 years post randomization.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 98508
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
    • Arizona
      • Phoenix, Arizona, United States, 85004
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Recruiting
        • Highlands Oncology Group - Fayetteville
        • Principal Investigator:
          • Joseph T. Beck
        • Contact:
      • Jonesboro, Arkansas, United States, 72401
        • Recruiting
        • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
        • Principal Investigator:
          • Aleksandar Jankov
        • Contact:
      • Rogers, Arkansas, United States, 72758
        • Recruiting
        • Highlands Oncology Group - Rogers
        • Principal Investigator:
          • Joseph T. Beck
        • Contact:
      • Springdale, Arkansas, United States, 72762
        • Recruiting
        • Highlands Oncology Group
        • Principal Investigator:
          • Joseph T. Beck
        • Contact:
    • California
      • Arroyo Grande, California, United States, 93420
      • Auburn, California, United States, 95602
      • Auburn, California, United States, 95603
        • Recruiting
        • Sutter Cancer Centers Radiation Oncology Services-Auburn
        • Principal Investigator:
          • Uma Suryadevara
        • Contact:
      • Berkeley, California, United States, 94704
        • Recruiting
        • Alta Bates Summit Medical Center-Herrick Campus
        • Principal Investigator:
          • Uma Suryadevara
        • Contact:
      • Burbank, California, United States, 91505
        • Recruiting
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Burlingame, California, United States, 94010
      • Cameron Park, California, United States, 95682
        • Recruiting
        • Sutter Cancer Centers Radiation Oncology Services-Cameron Park
        • Principal Investigator:
          • Uma Suryadevara
        • Contact:
      • Carmichael, California, United States, 95608
        • Recruiting
        • Mercy San Juan Medical Center
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Carmichael, California, United States, 95608
      • Castro Valley, California, United States, 94546
      • Davis, California, United States, 95616
      • Elk Grove, California, United States, 95758
      • Fremont, California, United States, 94538
      • Merced, California, United States, 95340
      • Modesto, California, United States, 95355
      • Mountain View, California, United States, 94040
        • Recruiting
        • Palo Alto Medical Foundation-Camino Division
        • Principal Investigator:
          • Uma Suryadevara
        • Contact:
      • Mountain View, California, United States, 94040
        • Recruiting
        • Palo Alto Medical Foundation-Gynecologic Oncology
        • Principal Investigator:
          • Uma Suryadevara
        • Contact:
      • Napa, California, United States, 94558
        • Recruiting
        • Providence Queen of The Valley
        • Principal Investigator:
          • Charles W. Drescher
        • Contact:
          • Site Public Contact
          • Phone Number: 707-521-3830
      • Novato, California, United States, 94945
      • Palo Alto, California, United States, 94301
      • Rocklin, California, United States, 95765
      • Roseville, California, United States, 95661
        • Recruiting
        • Sutter Cancer Centers Radiation Oncology Services-Roseville
        • Principal Investigator:
          • Uma Suryadevara
        • Contact:
      • Roseville, California, United States, 95661
      • Sacramento, California, United States, 95816
      • Sacramento, California, United States, 95816
      • San Francisco, California, United States, 94115
        • Recruiting
        • California Pacific Medical Center-Pacific Campus
        • Principal Investigator:
          • Uma Suryadevara
        • Contact:
      • San Luis Obispo, California, United States, 93401
      • San Mateo, California, United States, 94401
      • Santa Barbara, California, United States, 93105
      • Santa Cruz, California, United States, 95065
      • Santa Cruz, California, United States, 95065
        • Recruiting
        • Santa Cruz Radiation Oncology Medical Group
        • Principal Investigator:
          • Uma Suryadevara
        • Contact:
      • Santa Maria, California, United States, 93444
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Sutter Pacific Medical Foundation
        • Principal Investigator:
          • Uma Suryadevara
        • Contact:
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Providence Medical Foundation - Santa Rosa
        • Principal Investigator:
          • Charles W. Drescher
        • Contact:
          • Site Public Contact
          • Phone Number: 707-521-3830
      • Santa Rosa, California, United States, 95405
        • Recruiting
        • Providence Santa Rosa Memorial Hospital
        • Principal Investigator:
          • Charles W. Drescher
        • Contact:
          • Site Public Contact
          • Phone Number: 707-521-3830
      • Stockton, California, United States, 95204
        • Recruiting
        • Saint Joseph's Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 209-461-5257
        • Principal Investigator:
          • Shahzad Siddique
      • Sunnyvale, California, United States, 94086
      • Vallejo, California, United States, 94589
        • Recruiting
        • Sutter Solano Medical Center/Cancer Center
        • Principal Investigator:
          • Uma Suryadevara
        • Contact:
      • Woodland, California, United States, 95695
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
      • Colorado Springs, Colorado, United States, 80907
      • Colorado Springs, Colorado, United States, 80923
      • Durango, Colorado, United States, 81301
      • Durango, Colorado, United States, 81301
      • Lakewood, Colorado, United States, 80228
      • Longmont, Colorado, United States, 80501
      • Pueblo, Colorado, United States, 81004
      • Westminster, Colorado, United States, 80023
    • Connecticut
      • Stamford, Connecticut, United States, 06904
        • Recruiting
        • Stamford Hospital/Bennett Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 203-323-8944
        • Principal Investigator:
          • Salvatore A. Del Prete
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Recruiting
        • Beebe Medical Center
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Millville, Delaware, United States, 19967
        • Recruiting
        • Beebe South Coastal Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Helen F Graham Cancer Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Medical Oncology Hematology Consultants PA
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19718
        • Recruiting
        • Christiana Care Health System-Christiana Hospital
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Rehoboth Beach, Delaware, United States, 19971
        • Recruiting
        • Beebe Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Wilmington, Delaware, United States, 19801
        • Recruiting
        • Christiana Care Health System-Wilmington Hospital
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
    • Florida
      • Lakeland, Florida, United States, 33805
        • Recruiting
        • The Watson Clinic
        • Principal Investigator:
          • Shalini Mulaparthi
        • Contact:
          • Site Public Contact
          • Phone Number: 863-680-7780
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital/Winship Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
        • Principal Investigator:
          • Olumide B. Gbolahan
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Contact:
          • Site Public Contact
          • Phone Number: 888-946-7447
        • Principal Investigator:
          • Olumide B. Gbolahan
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Emory Saint Joseph's Hospital
        • Principal Investigator:
          • Olumide B. Gbolahan
        • Contact:
          • Site Public Contact
          • Phone Number: 404-851-7115
      • Decatur, Georgia, United States, 30033
      • Johns Creek, Georgia, United States, 30097
        • Recruiting
        • Emory Johns Creek Hospital
        • Principal Investigator:
          • Olumide B. Gbolahan
        • Contact:
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • Saint Luke's Cancer Institute - Boise
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Coeur d'Alene, Idaho, United States, 83814
        • Recruiting
        • Kootenai Health - Coeur d'Alene
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Fruitland, Idaho, United States, 83619
        • Recruiting
        • Saint Luke's Cancer Institute - Fruitland
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Saint Luke's Cancer Institute - Meridian
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Nampa, Idaho, United States, 83687
        • Recruiting
        • Saint Luke's Cancer Institute - Nampa
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Post Falls, Idaho, United States, 83854
        • Recruiting
        • Kootenai Clinic Cancer Services - Post Falls
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Sandpoint, Idaho, United States, 83864
        • Recruiting
        • Kootenai Clinic Cancer Services - Sandpoint
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Twin Falls, Idaho, United States, 83301
        • Recruiting
        • Saint Luke's Cancer Institute - Twin Falls
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
    • Illinois
      • Bloomington, Illinois, United States, 61704
        • Recruiting
        • Illinois CancerCare-Bloomington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Canton, Illinois, United States, 61520
        • Recruiting
        • Illinois CancerCare-Canton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Carbondale, Illinois, United States, 62902
        • Recruiting
        • Memorial Hospital of Carbondale
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Carterville, Illinois, United States, 62918
        • Recruiting
        • SIH Cancer Institute
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Carthage, Illinois, United States, 62321
        • Recruiting
        • Illinois CancerCare-Carthage
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Centralia, Illinois, United States, 62801
        • Recruiting
        • Centralia Oncology Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Contact:
        • Principal Investigator:
          • Prem Sobti
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois - Decatur
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Decatur Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Dixon, Illinois, United States, 61021
        • Recruiting
        • Illinois CancerCare-Dixon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 815-285-7800
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Contact:
        • Principal Investigator:
          • Prem Sobti
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Crossroads Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Eureka, Illinois, United States, 61530
        • Recruiting
        • Illinois CancerCare-Eureka
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Galesburg, Illinois, United States, 61401
        • Recruiting
        • Illinois CancerCare-Galesburg
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Kewanee, Illinois, United States, 61443
        • Recruiting
        • Illinois CancerCare-Kewanee Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Macomb, Illinois, United States, 61455
        • Recruiting
        • Illinois CancerCare-Macomb
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Mattoon, Illinois, United States, 61938
        • Recruiting
        • Carle Physician Group-Mattoon/Charleston
        • Contact:
        • Principal Investigator:
          • Prem Sobti
      • Normal, Illinois, United States, 61761
        • Recruiting
        • Carle BroMenn Medical Center
        • Contact:
        • Principal Investigator:
          • Prem Sobti
      • Normal, Illinois, United States, 61761
        • Recruiting
        • Carle Cancer Institute Normal
        • Contact:
        • Principal Investigator:
          • Prem Sobti
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Cancer Care Center of O'Fallon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • HSHS Saint Elizabeth's Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Ottawa, Illinois, United States, 61350
        • Recruiting
        • Illinois CancerCare-Ottawa Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Pekin, Illinois, United States, 61554
        • Recruiting
        • Illinois CancerCare-Pekin
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peoria, Illinois, United States, 61615
        • Recruiting
        • Illinois CancerCare-Peoria
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peru, Illinois, United States, 61354
        • Recruiting
        • Illinois CancerCare-Peru
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peru, Illinois, United States, 61354
        • Recruiting
        • Valley Radiation Oncology
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 815-664-4141
      • Princeton, Illinois, United States, 61356
        • Recruiting
        • Illinois CancerCare-Princeton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 217-545-7929
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Springfield Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 800-444-7541
      • Springfield, Illinois, United States, 62781
        • Recruiting
        • Springfield Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Prem Sobti
      • Washington, Illinois, United States, 61571
        • Recruiting
        • Illinois CancerCare - Washington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
    • Iowa
      • Ames, Iowa, United States, 50010
        • Recruiting
        • Mary Greeley Medical Center
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Ames, Iowa, United States, 50010
        • Recruiting
        • McFarland Clinic - Ames
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
      • Boone, Iowa, United States, 50036
        • Suspended
        • McFarland Clinic - Boone
      • Cedar Rapids, Iowa, United States, 52403
        • Recruiting
        • Mercy Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 319-365-4673
        • Principal Investigator:
          • Deborah W. Wilbur
      • Cedar Rapids, Iowa, United States, 52403
        • Recruiting
        • Oncology Associates at Mercy Medical Center
        • Principal Investigator:
          • Deborah W. Wilbur
        • Contact:
          • Site Public Contact
          • Phone Number: 319-363-2690
      • Clive, Iowa, United States, 50325
        • Recruiting
        • Mercy Cancer Center-West Lakes
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Creston, Iowa, United States, 50801
        • Recruiting
        • Greater Regional Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Mercy Medical Center - Des Moines
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Fort Dodge, Iowa, United States, 50501
        • Recruiting
        • McFarland Clinic - Trinity Cancer Center
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Jefferson, Iowa, United States, 50129
        • Suspended
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, United States, 50158
        • Recruiting
        • McFarland Clinic - Marshalltown
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • Mercy Medical Center-West Lakes
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
      • Corbin, Kentucky, United States, 40701
      • Lexington, Kentucky, United States, 40509
      • Lexington, Kentucky, United States, 40504
      • Lexington, Kentucky, United States, 40504
      • London, Kentucky, United States, 40741
      • Mount Sterling, Kentucky, United States, 40353
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70805
        • Recruiting
        • LSU Health Baton Rouge-North Clinic
        • Contact:
        • Principal Investigator:
          • Marshall P. Stagg
      • Baton Rouge, Louisiana, United States, 70808
        • Recruiting
        • Our Lady of The Lake
        • Principal Investigator:
          • Marshall P. Stagg
        • Contact:
          • Site Public Contact
          • Phone Number: 225-765-7659
      • Baton Rouge, Louisiana, United States, 70808
        • Recruiting
        • Our Lady of the Lake Physician Group
        • Contact:
        • Principal Investigator:
          • Marshall P. Stagg
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Recruiting
        • Sinai Hospital of Baltimore
        • Principal Investigator:
          • Pallavi P. Kumar
        • Contact:
          • Site Public Contact
          • Phone Number: 410-601-9083
      • Elkton, Maryland, United States, 21921
        • Recruiting
        • Christiana Care - Union Hospital
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Randallstown, Maryland, United States, 21133
      • Westminster, Maryland, United States, 21157
        • Recruiting
        • William E Kahlert Regional Cancer Center/Sinai Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 410-871-6400
        • Principal Investigator:
          • Pallavi P. Kumar
    • Michigan
      • Battle Creek, Michigan, United States, 49017
        • Recruiting
        • Bronson Battle Creek
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Escanaba, Michigan, United States, 49829
        • Recruiting
        • OSF Saint Francis Hospital and Medical Group
        • Principal Investigator:
          • Matthew L. Ryan
        • Contact:
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Trinity Health Grand Rapids Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • Bronson Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • West Michigan Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, United States, 49009
        • Recruiting
        • Beacon Kalamazoo Cancer Center
        • Principal Investigator:
          • Kathleen Y. Butler
        • Contact:
          • Site Public Contact
          • Phone Number: 574-647-7370
      • Kalamazoo, Michigan, United States, 49048
        • Recruiting
        • Beacon Kalamazoo
        • Principal Investigator:
          • Kathleen Y. Butler
        • Contact:
          • Site Public Contact
          • Phone Number: 574-647-7370
      • Muskegon, Michigan, United States, 49444
        • Recruiting
        • Trinity Health Muskegon Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Niles, Michigan, United States, 49120
        • Recruiting
        • Corewell Health Lakeland Hospitals - Niles Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 616-391-1230
        • Principal Investigator:
          • Kathleen Y. Butler
      • Norton Shores, Michigan, United States, 49444
        • Recruiting
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Reed City, Michigan, United States, 49677
        • Recruiting
        • Corewell Health Reed City Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Saint Joseph, Michigan, United States, 49085
        • Recruiting
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Saint Joseph, Michigan, United States, 49085
        • Recruiting
        • Corewell Health Lakeland Hospitals - Saint Joseph Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Traverse City, Michigan, United States, 49684
        • Recruiting
        • Munson Medical Center
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Wyoming, Michigan, United States, 49519
        • Recruiting
        • University of Michigan Health - West
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
    • Minnesota
      • Aitkin, Minnesota, United States, 56431
        • Recruiting
        • Riverwood Healthcare Center
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Baxter, Minnesota, United States, 56425
        • Recruiting
        • Essentia Health - Baxter Clinic
        • Principal Investigator:
          • Bret E. Friday
        • Contact:
          • Site Public Contact
          • Phone Number: 218-828-2880
      • Brainerd, Minnesota, United States, 56401
        • Recruiting
        • Essentia Health Saint Joseph's Medical Center
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Crosslake, Minnesota, United States, 56442
        • Recruiting
        • Essentia Health - Saint Joseph's Crosslake Clinic
        • Principal Investigator:
          • Bret E. Friday
        • Contact:
          • Site Public Contact
          • Phone Number: 218-692-1010
      • Deer River, Minnesota, United States, 56636
        • Recruiting
        • Essentia Health - Deer River Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Detroit Lakes, Minnesota, United States, 56501
        • Recruiting
        • Essentia Health Saint Mary's - Detroit Lakes Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • Essentia Health Cancer Center
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • Essentia Health Saint Mary's Medical Center
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • Miller-Dwan Hospital
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Ely, Minnesota, United States, 55731
        • Recruiting
        • Essentia Health - Ely Clinic
        • Principal Investigator:
          • Bret E. Friday
        • Contact:
          • Site Public Contact
          • Phone Number: 218-365-7900
      • Fosston, Minnesota, United States, 56542
        • Recruiting
        • Essentia Health - Fosston
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Hibbing, Minnesota, United States, 55746
        • Recruiting
        • Essentia Health Hibbing Clinic
        • Principal Investigator:
          • Bret E. Friday
        • Contact:
          • Site Public Contact
          • Phone Number: 218-786-3308
      • International Falls, Minnesota, United States, 56649
        • Recruiting
        • Essentia Health - International Falls Clinic
        • Principal Investigator:
          • Bret E. Friday
        • Contact:
          • Site Public Contact
          • Phone Number: 218-283-9431
      • Moose Lake, Minnesota, United States, 55767
        • Recruiting
        • Essentia Health - Moose Lake Clinic
        • Principal Investigator:
          • Bret E. Friday
        • Contact:
          • Site Public Contact
          • Phone Number: 218-485-4481
      • Park Rapids, Minnesota, United States, 56470
        • Recruiting
        • Essentia Health - Park Rapids
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Pequot Lakes, Minnesota, United States, 56472
        • Recruiting
        • Essentia Health - Saint Joseph's Pequot Lakes Clinic
        • Principal Investigator:
          • Bret E. Friday
        • Contact:
          • Site Public Contact
          • Phone Number: 218-568-4416
      • Pine River, Minnesota, United States, 56474
        • Recruiting
        • Essentia Health - Saint Joseph's Pine River Clinic
        • Principal Investigator:
          • Bret E. Friday
        • Contact:
          • Site Public Contact
          • Phone Number: 218-587-4416
      • Sandstone, Minnesota, United States, 55072
        • Recruiting
        • Essentia Health Sandstone
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Staples, Minnesota, United States, 56479
        • Recruiting
        • Essentia Health - Saint Joseph's Staples Clinic
        • Principal Investigator:
          • Bret E. Friday
        • Contact:
          • Site Public Contact
          • Phone Number: 218-894-7870
      • Virginia, Minnesota, United States, 55792
        • Recruiting
        • Essentia Health Virginia Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
    • Mississippi
      • Columbus, Mississippi, United States, 39705
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Golden Triangle
        • Principal Investigator:
          • Aleksandar Jankov
        • Contact:
      • Grenada, Mississippi, United States, 38901
        • Recruiting
        • Baptist Cancer Center-Grenada
        • Principal Investigator:
          • Aleksandar Jankov
        • Contact:
      • New Albany, Mississippi, United States, 38652
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Union County
        • Principal Investigator:
          • Aleksandar Jankov
        • Contact:
      • Oxford, Mississippi, United States, 38655
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Oxford
        • Principal Investigator:
          • Aleksandar Jankov
        • Contact:
      • Southhaven, Mississippi, United States, 38671
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Desoto
        • Principal Investigator:
          • Aleksandar Jankov
        • Contact:
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Saint Francis Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 573-334-2230
          • Email: sfmc@sfmc.net
      • Farmington, Missouri, United States, 63640
        • Recruiting
        • Parkland Health Center - Farmington
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Sainte Genevieve, Missouri, United States, 63670
        • Recruiting
        • Sainte Genevieve County Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • St Louis, Missouri, United States, 63131
        • Recruiting
        • Missouri Baptist Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Sullivan, Missouri, United States, 63080
        • Recruiting
        • Missouri Baptist Sullivan Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Sunset Hills, Missouri, United States, 63127
        • Recruiting
        • BJC Outpatient Center at Sunset Hills
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
    • Montana
      • Anaconda, Montana, United States, 59711
        • Recruiting
        • Community Hospital of Anaconda
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Billings, Montana, United States, 59101
        • Recruiting
        • Billings Clinic Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Bozeman, Montana, United States, 59715
        • Recruiting
        • Bozeman Health Deaconess Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Great Falls Clinic
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Benefis Sletten Cancer Institute
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Havre, Montana, United States, 59501
        • Recruiting
        • Hi-Line Sletten Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Helena, Montana, United States, 59601
        • Recruiting
        • Benefis Helena Specialty Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Logan Health Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Missoula, Montana, United States, 59802
        • Recruiting
        • Saint Patrick Hospital - Community Hospital
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Community Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
      • Kearney, Nebraska, United States, 68847
      • Omaha, Nebraska, United States, 68122
      • Omaha, Nebraska, United States, 68124
      • Omaha, Nebraska, United States, 68130
      • Omaha, Nebraska, United States, 68131
    • North Carolina
      • Clinton, North Carolina, United States, 28328
        • Recruiting
        • Southeastern Medical Oncology Center-Clinton
        • Contact:
        • Principal Investigator:
          • Samer S. Kasbari
      • Goldsboro, North Carolina, United States, 27534
        • Recruiting
        • Southeastern Medical Oncology Center-Goldsboro
        • Contact:
        • Principal Investigator:
          • Samer S. Kasbari
      • Jacksonville, North Carolina, United States, 28546
        • Recruiting
        • Southeastern Medical Oncology Center-Jacksonville
        • Principal Investigator:
          • Samer S. Kasbari
        • Contact:
      • Pinehurst, North Carolina, United States, 28374
        • Recruiting
        • FirstHealth of the Carolinas-Moore Regional Hospital
        • Contact:
        • Principal Investigator:
          • Charles S. Kuzma
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Recruiting
        • Essentia Health Cancer Center-South University Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Jamestown, North Dakota, United States, 58401
        • Recruiting
        • Essentia Health - Jamestown Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Miami Valley Hospital South
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Cancer Center-UC Medical Center
        • Principal Investigator:
          • Olugbenga Olowokure (Gbenga)
        • Contact:
      • Cincinnati, Ohio, United States, 45220
      • Cincinnati, Ohio, United States, 45242
      • Cincinnati, Ohio, United States, 45247
      • Cincinnati, Ohio, United States, 45255
      • Dayton, Ohio, United States, 45409
        • Recruiting
        • Miami Valley Hospital
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Dayton, Ohio, United States, 45415
        • Recruiting
        • Miami Valley Hospital North
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Dayton, Ohio, United States, 45409
        • Recruiting
        • Premier Blood and Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 937-276-8320
        • Principal Investigator:
          • Tarek M. Sabagh
      • Franklin, Ohio, United States, 45005-1066
        • Recruiting
        • Atrium Medical Center-Middletown Regional Hospital
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Greenville, Ohio, United States, 45331
        • Recruiting
        • Miami Valley Cancer Care and Infusion
        • Principal Investigator:
          • Tarek M. Sabagh
        • Contact:
          • Site Public Contact
          • Phone Number: 937-569-7515
      • Troy, Ohio, United States, 45373
        • Recruiting
        • Upper Valley Medical Center
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • West Chester, Ohio, United States, 45069
        • Recruiting
        • University of Cincinnati Cancer Center-West Chester
        • Principal Investigator:
          • Olugbenga Olowokure (Gbenga)
        • Contact:
    • Oregon
      • Bend, Oregon, United States, 97701
        • Recruiting
        • Saint Charles Health System
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Clackamas Radiation Oncology Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Coos Bay, Oregon, United States, 97420
        • Recruiting
        • Bay Area Hospital
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Hood River, Oregon, United States, 97031
        • Recruiting
        • Providence Hood River Memorial Hospital
        • Principal Investigator:
          • Charles W. Drescher
        • Contact:
      • Newberg, Oregon, United States, 97132
        • Recruiting
        • Providence Newberg Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Oregon City, Oregon, United States, 97045
        • Recruiting
        • Providence Willamette Falls Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Saint Vincent Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Redmond, Oregon, United States, 97756
        • Recruiting
        • Saint Charles Health System-Redmond
        • Contact:
          • Site Public Contact
          • Phone Number: 541-706-2909
        • Principal Investigator:
          • Charles W. Drescher
    • Pennsylvania
      • Chadds Ford, Pennsylvania, United States, 19317
        • Recruiting
        • Christiana Care Health System-Concord Health Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Recruiting
        • Rapid City Regional Hospital
        • Principal Investigator:
          • Abdel-Ghani Azzouqa
        • Contact:
    • Tennessee
      • Collierville, Tennessee, United States, 38017
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Collierville
        • Principal Investigator:
          • Aleksandar Jankov
        • Contact:
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Memphis
        • Principal Investigator:
          • Aleksandar Jankov
        • Contact:
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Schar Cancer Institute
        • Contact:
        • Principal Investigator:
          • Raymond C. Wadlow
      • Fairfax, Virginia, United States, 22033
        • Recruiting
        • Inova Fair Oaks Hospital
        • Contact:
        • Principal Investigator:
          • Raymond C. Wadlow
    • Washington
      • Aberdeen, Washington, United States, 98520
        • Recruiting
        • Providence Regional Cancer System-Aberdeen
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Bellingham, Washington, United States, 98225
        • Recruiting
        • PeaceHealth Saint Joseph Medical Center
        • Principal Investigator:
          • Charles W. Drescher
        • Contact:
      • Centralia, Washington, United States, 98531
        • Recruiting
        • Providence Regional Cancer System-Centralia
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Edmonds, Washington, United States, 98026
        • Recruiting
        • Swedish Cancer Institute-Edmonds
        • Principal Investigator:
          • Charles W. Drescher
        • Contact:
      • Everett, Washington, United States, 98201
        • Recruiting
        • Providence Regional Cancer Partnership
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Issaquah, Washington, United States, 98029
        • Recruiting
        • Swedish Cancer Institute-Issaquah
        • Principal Investigator:
          • Charles W. Drescher
        • Contact:
      • Kennewick, Washington, United States, 99336
        • Recruiting
        • Kadlec Clinic Hematology and Oncology
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Lacey, Washington, United States, 98503
        • Recruiting
        • Providence Regional Cancer System-Lacey
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Longview, Washington, United States, 98632
        • Recruiting
        • PeaceHealth Saint John Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Mount Vernon, Washington, United States, 98274
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center-First Hill
        • Principal Investigator:
          • Charles W. Drescher
        • Contact:
      • Seattle, Washington, United States, 98107
        • Recruiting
        • Swedish Medical Center-Ballard Campus
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Seattle, Washington, United States, 98122-5711
        • Recruiting
        • Swedish Medical Center-Cherry Hill
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center - Montlake
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-8824
        • Principal Investigator:
          • Rachael A. Safyan
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-8824
        • Principal Investigator:
          • Rachael A. Safyan
      • Sedro-Woolley, Washington, United States, 98284
        • Recruiting
        • PeaceHealth United General Medical Center
        • Principal Investigator:
          • Charles W. Drescher
        • Contact:
      • Silverdale, Washington, United States, 98383
      • Spokane, Washington, United States, 99202
        • Recruiting
        • Cancer Care Northwest - Spokane South
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Spokane, Washington, United States, 99216
        • Recruiting
        • Cancer Care Northwest-Valley
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Spokane, Washington, United States, 99218
        • Recruiting
        • Cancer Care Northwest-North Spokane
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Vancouver, Washington, United States, 98664
        • Recruiting
        • PeaceHealth Southwest Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Walla Walla, Washington, United States, 99362
        • Recruiting
        • Providence Saint Mary Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
    • Wisconsin
      • Ashland, Wisconsin, United States, 54806
        • Recruiting
        • Duluth Clinic Ashland
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Ashland, Wisconsin, United States, 54806
        • Recruiting
        • Northwest Wisconsin Cancer Center
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Green Bay, Wisconsin, United States, 54301
        • Recruiting
        • Saint Vincent Hospital Cancer Center Green Bay
        • Principal Investigator:
          • Matthew L. Ryan
        • Contact:
      • Green Bay, Wisconsin, United States, 54303
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Saint Mary's
        • Principal Investigator:
          • Matthew L. Ryan
        • Contact:
      • Hayward, Wisconsin, United States, 54843
        • Recruiting
        • Essentia Health-Hayward Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Hayward, Wisconsin, United States, 54843
        • Recruiting
        • Tamarack Health Hayward Medical Center
        • Principal Investigator:
          • Bret E. Friday
        • Contact:
          • Site Public Contact
          • Phone Number: 218-568-4416
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Gundersen Lutheran Medical Center
        • Contact:
        • Principal Investigator:
          • David E. Marinier
      • Oconto Falls, Wisconsin, United States, 54154
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Oconto Falls
        • Principal Investigator:
          • Matthew L. Ryan
        • Contact:
      • Sheboygan, Wisconsin, United States, 53081
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Sheboygan
        • Principal Investigator:
          • Matthew L. Ryan
        • Contact:
      • Sheboygan, Wisconsin, United States, 53081
        • Recruiting
        • Sheboygan Physicians Group
        • Principal Investigator:
          • Matthew L. Ryan
        • Contact:
      • Spooner, Wisconsin, United States, 54801
        • Recruiting
        • Essentia Health-Spooner Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Sturgeon Bay, Wisconsin, United States, 54235-1495
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
        • Principal Investigator:
          • Matthew L. Ryan
        • Contact:
      • Superior, Wisconsin, United States, 54880
        • Recruiting
        • Essentia Health Saint Mary's Hospital - Superior
        • Principal Investigator:
          • Bret E. Friday
        • Contact:
          • Site Public Contact
          • Phone Number: 701-364-6272
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001
        • Recruiting
        • Memorial Hospital of Laramie County
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Cody, Wyoming, United States, 82414
        • Recruiting
        • Billings Clinic-Cody
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must have a histologically or cytologically confirmed diagnosis of ductal adenocarcinoma of the pancreas

  • Participants must have previously documented KRAS wild type (i.e. absence of any KRAS mutation) and BRAF V600E wild type (i.e. absence of a BRAF V600E mutation) status determined by tumor tissue-based NGS assay. The testing must be done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC), College of American Pathologists (CAP), or similar certification status

    • NOTE: Blood-based next generation sequencing (NGS) assays, such as circulating tumor deoxyribonucleic acid (DNA) (ctDNA) or liquid biopsies, will not be accepted for meeting eligibility criteria
  • Participants must have documented unresectable and/or metastatic disease on CT or magnetic resonance imaging (MRI) imaging completed prior to randomization. Imaging must have been completed within 28 days prior to randomization for participants with measurable disease. CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to randomization. All disease must be assessed and documented on the Baseline Tumor Assessment Form (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)

  • Participants must not have known mutations in PTEN, NRAS, EGFR extracellular domain exons 1-16, no amplifications of HER2 and MET, and no gene fusions of RET, NTRK1, and ALK by tumor tissue-based NGS analysis

    • NOTE: Participants who are not tested for these mutations are eligible if they have previously documented KRAS wild type (i.e. absence of any KRAS mutation) and BRAF V600E wild type (i.e. absence of a BRAF V600E mutation) status

  • Participants must not have known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 28 days before randomization (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day).

    • NOTE: Participants must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment

  • Participants must have received only one line of prior systemic cytotoxic chemotherapy for locally advanced or metastatic PDA, and have radiographically progressed, refractory, or intolerant to this therapy.

    • Prior neoadjuvant or adjuvant therapy with 5-FU or gemcitabine-based chemotherapy counts as a line of therapy if the participant's disease progressed to locally advanced or metastatic disease within 6 months of completing treatment
    • Participants with cancers harboring molecular alterations including microsatellite instability (MSI-high), elevated tumor mutational burden (TMB) (TMB ≥ 10 mut/Mb), and FGFR1-3, NRG1, and ROS fusions are allowed to have received an additional line of targeted therapy applicable to the respective molecular alterations at the treating investigators discretion.
    • Prior maintenance therapy with Olaparib or Rucaparib for germline or somatic BRCA1/2 or PALB2 mutations does not count as a line of therapy.
  • Participants must not have prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab)
  • Participants must not have prior treatment with an EGFR tyrosine kinase inhibitor (e.g., erlotinib)
  • Participants must not have received any pancreatic anticancer therapy (e.g., standard of care or investigational chemotherapy, molecularly targeted therapy, or radiation) within 14 days prior to randomization
  • Participants must not have a known contraindication to receiving chosen chemotherapy backbone at the planned doses in accordance with the local approved label
  • Participant must be ≥ 18 years old at the time of randomization
  • Participants must have Zubrod performance status of 0-2
  • Participants must have a complete medical history and physical exam within 28 days prior to randomization (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)

  • Absolute neutrophil count ≥ 1.0 x 10^3/uL (within 28 days prior to randomization) (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)

    • Note: Use of growth factor support (e.g., Granulocyte Colony-Stimulating Factor [G-CSF] or romiplostim [Nplate]) is permitted, and prior use does not constitute an exclusion criterion. Recent blood transfusions are also allowed

  • Hemoglobin ≥ 8 g/dL (within 28 days prior to randomization) (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)

    • Note: Use of growth factor support (e.g., G-CSF or romiplostim [Nplate]) is permitted, and prior use does not constitute an exclusion criterion. Recent blood transfusions are also allowed

  • Platelets ≥ 75 x 10^3/uL (within 28 days prior to randomization) (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)

    • Note: Use of growth factor support (e.g., G-CSF or romiplostim [Nplate]) is permitted, and prior use does not constitute an exclusion criterion. Recent blood transfusions are also allowed
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) (within 28 days prior to randomization) (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)
  • Aspartate aminotransferase (AST) ≤ 10 x upper limits of normal (ULN) (within 28 days prior to randomization) (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)
  • Participants must have a creatinine ≤ the IULN OR measured OR calculated creatinine clearance ≥ 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration (In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient participant scheduling without exceeding the guidelines. If Day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day)
  • Participants with known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to randomization
  • Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated
  • Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization, if indicated
  • Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
  • Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
  • Participants must be offered the opportunity to participate in specimen banking
  • Participants who can complete patient reported outcomes (FACT-G and PRO-CTCAE) questionnaires in English or Spanish must be offered the opportunity to participate in the quality-of-life studies

  • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.

    • For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A (panitumumab and standard chemotherapy)
Patients receive panitumumab IV over 30-90 minutes on days 1 and 15. Patients also receive either nanoliposomal irinotecan IV over 90 minutes on days 1 and 15, leucovorin IV over 30 minutes on days 1 and 15, and 5-FU IV over 46 hours on days 1-3 and 15-17 or irinotecan IV over 90 minutes, leucovorin IV over 90-120 minutes on days 1 and 15, 5-FU IV bolus over 5-15 minutes on days 1 and 15 and 5FU IV continuous over 46 hours on days 1-3 and 15-17 or nab-paclitaxel IV over 30 minutes, and gemcitabine IV over 30 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and blood sample collection throughout the study.
Other: Questionnaire Administration
Ancillary studies
Drug: Gemcitabine
Given IV
Other Names:
  • dFdCyd
  • dFdC
  • Difluorodeoxycytidine
Drug: Nab-paclitaxel
Given IV
Other Names:
  • ABI-007
  • Abraxane
  • Albumin-bound Paclitaxel
  • ABI 007
  • Albumin-Stabilized Nanoparticle Paclitaxel
  • Nanoparticle Albumin-bound Paclitaxel
  • Nanoparticle Paclitaxel
  • Paclitaxel Albumin
  • paclitaxel albumin-stabilized nanoparticle formulation
  • Protein-bound Paclitaxel
  • ABI007
  • Paclitaxel Protein-Bound
  • Paclitaxel Nanoparticle Albumin-bound
  • Naveruclif
Biological: Panitumumab
Given IV
Other Names:
  • ABX-EGF
  • ABX-EGF Monoclonal Antibody
  • ABX-EGF, Clone E7.6.3
  • MoAb ABX-EGF
  • Monoclonal Antibody ABX-EGF
  • Vectibix
  • E7.6.3
  • Human IgG2K Monoclonal Antibody
  • MoAb E7.6.3
  • Monoclonal Antibody E7.6.3
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Drug: Fluorouracil
Given IV
Other Names:
  • 5-Fluracil
  • Fluracil
  • 5 Fluorouracil
  • 5 Fluorouracilum
  • 5 FU
  • 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
  • 5-Fluorouracil
  • 5-Fu
  • 5FU
  • AccuSite
  • Carac
  • Fluoro Uracil
  • Fluouracil
  • Flurablastin
  • Fluracedyl
  • Fluril
  • Fluroblastin
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757
Drug: Leucovorin
Given IV
Other Names:
  • Folinic acid
Drug: Irinotecan
Given IV
Procedure: Computed Tomography
Undergo CT scan
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
Drug: Irinotecan Sucrosofate
Given IV
Other Names:
  • Onivyde
  • MM-398
  • PEP02
  • Irinotecan Liposome
  • nal-IRI
  • Nanoliposomal Irinotecan
  • Nanoparticle Liposome Formulation of Irinotecan
  • MM 398
  • MM398
  • PEP-02
  • inotecan Hydrochloride as Sucrosulfate Salt Form Liposomal Formulation
  • Irinotecan Sucrosofate Liposome
  • Irinotecan Sucrosofate-containing Pegylated Liposomal Formulation
  • Nanoliposomal Irinotecan as Sucrosofate
  • PEP 02
Active Comparator: Arm B (standard chemotherapy)
Patients receive either nanoliposomal irinotecan IV over 90 minutes on days 1 and 15, leucovorin IV over 30 minutes on days 1 and 15, and 5-FU IV over 46 hours on days 1-3 and 15-17 or irinotecan IV over 90 minutes, leucovorin IV over 90-120 minutes on days 1 and 15, 5-FU IV bolus over 5-15 minutes on days 1 and 15 and 5FU IV continuous over 46 hours on days 1-3 and 15-17 or nab-paclitaxel IV over 30 minutes, and gemcitabine IV over 30 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and blood sample collection throughout the study.
Other: Questionnaire Administration
Ancillary studies
Drug: Gemcitabine
Given IV
Other Names:
  • dFdCyd
  • dFdC
  • Difluorodeoxycytidine
Drug: Nab-paclitaxel
Given IV
Other Names:
  • ABI-007
  • Abraxane
  • Albumin-bound Paclitaxel
  • ABI 007
  • Albumin-Stabilized Nanoparticle Paclitaxel
  • Nanoparticle Albumin-bound Paclitaxel
  • Nanoparticle Paclitaxel
  • Paclitaxel Albumin
  • paclitaxel albumin-stabilized nanoparticle formulation
  • Protein-bound Paclitaxel
  • ABI007
  • Paclitaxel Protein-Bound
  • Paclitaxel Nanoparticle Albumin-bound
  • Naveruclif
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Drug: Fluorouracil
Given IV
Other Names:
  • 5-Fluracil
  • Fluracil
  • 5 Fluorouracil
  • 5 Fluorouracilum
  • 5 FU
  • 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
  • 5-Fluorouracil
  • 5-Fu
  • 5FU
  • AccuSite
  • Carac
  • Fluoro Uracil
  • Fluouracil
  • Flurablastin
  • Fluracedyl
  • Fluril
  • Fluroblastin
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757
Drug: Leucovorin
Given IV
Other Names:
  • Folinic acid
Drug: Irinotecan
Given IV
Procedure: Computed Tomography
Undergo CT scan
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
Drug: Irinotecan Sucrosofate
Given IV
Other Names:
  • Onivyde
  • MM-398
  • PEP02
  • Irinotecan Liposome
  • nal-IRI
  • Nanoliposomal Irinotecan
  • Nanoparticle Liposome Formulation of Irinotecan
  • MM 398
  • MM398
  • PEP-02
  • inotecan Hydrochloride as Sucrosulfate Salt Form Liposomal Formulation
  • Irinotecan Sucrosofate Liposome
  • Irinotecan Sucrosofate-containing Pegylated Liposomal Formulation
  • Nanoliposomal Irinotecan as Sucrosofate
  • PEP 02

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: From date of randomization to date of death due to any cause, assessed up to 3 years
Analysis of OS will be conducted in all eligible participants according to the intent-to-treat principle using a 1-sided stratified log rank test.
From date of randomization to date of death due to any cause, assessed up to 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Up to 3 years after randomization
Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Will be compared across treatment arms via Fisher's exact test.
Up to 3 years after randomization
Disease control rate
Time Frame: Up to 3 years after randomization
Will be compared across treatment arms via Fisher's exact test.
Up to 3 years after randomization
Duration of response (DoR)
Time Frame: Up to 3 years after randomization
The distributions of DoR will be estimated using the method of Kaplan-Meier and compared using the stratified log rank test.
Up to 3 years after randomization
Progression free survival (PFS)
Time Frame: From date of randomization to date of first documentation of progression or symptomatic deterioration (per RECIST 1.1), or death due to any cause, up to 3 years
The distributions of PFS will be estimated using the method of Kaplan-Meier and compared using the stratified log rank test.
From date of randomization to date of first documentation of progression or symptomatic deterioration (per RECIST 1.1), or death due to any cause, up to 3 years
Incidence of adverse events
Time Frame: Up to 30 days after last study treatment
Up to 30 days after last study treatment
OS in participants with MAPK negative cancers
Time Frame: From date of randomization to date of death due to any cause, assessed up to 3 years
The distributions of OS will be estimated using the method of Kaplan-Meier and compared using the stratified log rank test.
From date of randomization to date of death due to any cause, assessed up to 3 years
PFS in participants with MAPK negative cancers
Time Frame: From date of randomization to date of first documentation of progression or symptomatic deterioration (per RECIST 1.1), or death due to any cause, up to 3 years
The distributions of PFS will be estimated using the method of Kaplan-Meier and compared using the stratified log rank test.
From date of randomization to date of first documentation of progression or symptomatic deterioration (per RECIST 1.1), or death due to any cause, up to 3 years
ORR in participants with MAPK negative cancers
Time Frame: Up to 3 years after randomization
Will be compared across treatment arms via Fisher's exact test.
Up to 3 years after randomization

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health-related quality of life (QOL)
Time Frame: At 8 weeks after randomization
Measured by the Functional Assessment of Cancer Therapy - General (FACT-G) total score. Analysis will be conducted using multiple linear regression analysis, adjusting for the clinical study-specified stratification factors (which are also anticipated to influence QOL endpoints), and the baseline score as covariates.
At 8 weeks after randomization
Impact of treatment toxicity
Time Frame: At 8 weeks after randomization
Measured by the Functional Assessment of Chronic Illness Therapy Item GP5 (FACIT Item GP5). Analysis will be conducted using multiple linear regression analysis, adjusting for the clinical study-specified stratification factors, and the baseline score as covariates.
At 8 weeks after randomization
Changes in health related QOL
Time Frame: Baseline up to 24 weeks after randomization
Will be assessed using FACT-G total score. Linear regression models will be used for longitudinal modeling, with robust errors estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. Covariates for longitudinal modeling will include intervention assignment, the assessment timepoint, the baseline score, and the stratification factors. The potential for differential dropout by arm will be mitigated by reminder notifications to site investigators to encourage proper assessment and submission of forms at every required time point for all participants. Cohort plots will be prepared to examine the extent to which missing data are informative (i.e., scores are higher (worse) for participants just before their data are missing for the subsequent assessment). If there is evidence of non-random dropout, pattern-mixture models will be utilized as a sensitivity analysis.
Baseline up to 24 weeks after randomization
Change in impact of treatment toxicity
Time Frame: Baseline up to 24 weeks post randomization
Will be assessed using FACIT Item GP5. Linear regression models will be used for longitudinal modeling, with robust errors estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. Covariates for longitudinal modeling will include intervention assignment, the assessment timepoint, the baseline score, and the stratification factors. The potential for differential dropout by arm will be mitigated by reminder notifications to site investigators to encourage proper assessment and submission of forms at every required time point for all participants. Cohort plots will be prepared to examine the extent to which missing data are informative (i.e., scores are higher (worse) for participants just before their data are missing for the subsequent assessment). If there is evidence of non-random dropout, pattern-mixture models will be utilized as a sensitivity analysis.
Baseline up to 24 weeks post randomization
Patient reported symptoms
Time Frame: Up to 30 days after last study treatment
Patient-reported symptoms will be assessed by treatment arm using selected patient reported outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) items including gastrointestinal, dermatologic as well as constitutional symptoms of pain and fatigue. For each of the PRO-CTCAE adverse events examined, the scores for each attribute (frequency, severity and/or interference) will be presented descriptively using summary statistics at each assessment time. Additionally, the worst severity and/or interference over the entire course will be summarized.
Up to 30 days after last study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SWOG Cancer Research Network

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rachael A Safyan, SWOG Cancer Research Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 13, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S2433 (Other Identifier: CTEP)
  • U10CA180888 (U.S. NIH Grant/Contract)
  • NCI-2025-03014 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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