Combination Chemotherapy With or Without Hypofractionated Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer

April 28, 2022 updated by: Alliance for Clinical Trials in Oncology

Preoperative Extended Chemotherapy vs. Chemotherapy Plus Hypofractionated Radiation Therapy for Borderline Resectable Adenocarcinoma of the Head of the Pancreas

This randomized phase II trial studies how well combination chemotherapy (mFOLFIRINOX) with or without hypofractionated radiation therapy before surgery works in patients with pancreatic cancer that can be removed by surgery. Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, and irinotecan hydrochloride, 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. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. It is not yet known if combination chemotherapy is more effective with or without hypofractionated radiation therapy before surgery in treating patients with pancreatic cancer.

Study Overview

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate and estimate 18 months overall survival (OS) rate of patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC) receiving neoadjuvant therapy.

SECONDARY OBJECTIVES:

I. To evaluate and estimate the R0 resection rates in patients receiving each of the two multimodality treatment regimens.

II. To evaluate and estimate the event-free survival in patients receiving each of the two multimodality treatment regimens.

III. To evaluate and estimate the pathologic compete response (pCR) rates in patients receiving each of the two multimodality treatment regimens.

IV. To assess the adverse events (AE) profile and safety of each treatment arm.

TERTIARY OBJECTIVES:

I. To test the effect of the rs2853564 vitamin D receptor (VDR) variant on OS rate and discover novel candidate genes associated with OS and severe toxicity of chemotherapy by using genome-wide genotyping approaches.

II. To evaluate risk classification previously developed by Koay et al using normalized area under the enhancement curve (NAUC).

III. To access prognostic value of NAUC ratio defined as post-neoadjuvant NAUC divided by pre-neoadjuvant therapy NAUC.

IV. To evaluate risk classification previously developed by Koay et al using delta measure.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive oxaliplatin intravenously (IV) over 2 hours, irinotecan IV over 90 minutes, and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 14 days for 8 courses in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive oxaliplatin intravenously (IV) over 2 hours, irinotecan IV over 90 minutes, and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 14 days for 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive either stereotactic body radiation therapy (SBRT) or hypofractionated image guided radiation therapy (HIGRT) on days 1-5 of course 8.

SURGERY Within 4 to 8 weeks after the last dose of chemotherapy (arm A) or of radiation (arm B), patients considered surgical candidates for resection (after central review) will undergo surgery at the registering institution.

ADJUVANT CHEMOTHERAPY Within 4-12 weeks from the date of surgery, patients will receive oxaliplatin IV over 2 hours and leucovorin IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46-48 hours on days 1-2. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 16 weeks for 2 years, then every 6 months for 5 years.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 2

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

    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network-Princess Margaret Hospital
    • Alabama
      • Mobile, Alabama, United States, 36688
        • University of South Alabama Mitchell Cancer Institute
      • Mobile, Alabama, United States, 36607
        • Southern Cancer Center PC-Mobile
      • Mobile, Alabama, United States, 36608
        • Southern Cancer Center PC-Springhill
    • California
      • Antioch, California, United States, 94531
        • Kaiser Permanente-Deer Valley Medical Center
      • Berkeley, California, United States, 94704
        • Alta Bates Summit Medical Center-Herrick Campus
      • Clovis, California, United States, 93611
        • University Oncology Associates
      • Fremont, California, United States, 94538
        • Kaiser Permanente-Fremont
      • Fresno, California, United States, 93720
        • Kaiser Permanente-Fresno
      • La Jolla, California, United States, 92093
        • UC San Diego Moores Cancer Center
      • Los Angeles, California, United States, 90033
        • USC / Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90033
        • Los Angeles County-USC Medical Center
      • Modesto, California, United States, 95356
        • Kaiser Permanente-Modesto
      • Oakland, California, United States, 94611
        • Kaiser Permanente-Oakland
      • Orange, California, United States, 92868
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Redwood City, California, United States, 94063
        • Kaiser Permanente-Redwood City
      • Richmond, California, United States, 94801
        • Kaiser Permanente-Richmond
      • Roseville, California, United States, 95661
        • Kaiser Permanente-Roseville
      • Sacramento, California, United States, 95817
        • University of California Davis Comprehensive Cancer Center
      • Sacramento, California, United States, 95823
        • Kaiser Permanente-South Sacramento
      • Sacramento, California, United States, 95825
        • Kaiser Permanente - Sacramento
      • San Francisco, California, United States, 94115
        • Kaiser Permanente-San Francisco
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center-Pacific Campus
      • San Jose, California, United States, 95119
        • Kaiser Permanente-Santa Teresa-San Jose
      • San Leandro, California, United States, 94577
        • Kaiser Permanente San Leandro
      • San Rafael, California, United States, 94903
        • Kaiser Permanente-San Rafael
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente Medical Center - Santa Clara
      • Santa Rosa, California, United States, 95403
        • Kaiser Permanente-Santa Rosa
      • South San Francisco, California, United States, 94080
        • Kaiser Permanente-South San Francisco
      • Stockton, California, United States, 95210
        • Kaiser Permanente-Stockton
      • Sunnyvale, California, United States, 94086
        • Palo Alto Medical Foundation-Sunnyvale
      • Vacaville, California, United States, 95688
        • Kaiser Permanente Medical Center-Vacaville
      • Vallejo, California, United States, 94589
        • Kaiser Permanente-Vallejo
      • Walnut Creek, California, United States, 94596
        • Kaiser Permanente-Walnut Creek
    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Care Health System-Christiana Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital
    • Florida
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
      • Orlando, Florida, United States, 32803
        • Florida Hospital Orlando
      • Pembroke Pines, Florida, United States, 33028
        • Memorial Hospital West
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Northwest Community Hospital
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60637
        • University of Chicago Comprehensive Cancer Center
      • Evanston, Illinois, United States, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Geneva, Illinois, United States, 60134
        • Northwestern Medicine Cancer Center Delnor
      • Glenview, Illinois, United States, 60026
        • NorthShore University HealthSystem-Glenbrook Hospital
      • Highland Park, Illinois, United States, 60035
        • NorthShore University HealthSystem-Highland Park Hospital
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
      • Naperville, Illinois, United States, 60540
        • Edward Hospital/Cancer Center
      • Plainfield, Illinois, United States, 60585
        • Edward Hospital/Cancer Center?Plainfield
      • Warrenville, Illinois, United States, 60555
        • Northwestern Medicine Cancer Center Warrenville
    • Indiana
      • Goshen, Indiana, United States, 46526
        • Goshen Center for Cancer Care
      • Indianapolis, Indiana, United States, 46202
        • Indiana University/Melvin and Bren Simon Cancer Center
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Iowa Methodist Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Cancer Center
      • Westwood, Kansas, United States, 66205
        • University of Kansas Hospital-Westwood Cancer Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky/Markey Cancer Center
      • Louisville, Kentucky, United States, 40202
        • The James Graham Brown Cancer Center at University of Louisville
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center Jefferson
    • Maine
      • Biddeford, Maine, United States, 04005
        • MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
      • Sanford, Maine, United States, 04073
        • MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
      • Scarborough, Maine, United States, 04074
        • Maine Medical Center- Scarborough Campus
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University/Sidney Kimmel Cancer Center
      • Baltimore, Maryland, United States, 21229
        • Saint Agnes Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical School
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center
      • Ann Arbor, Michigan, United States, 48106
        • Saint Joseph Mercy Hospital
      • Battle Creek, Michigan, United States, 49017
        • Bronson Battle Creek
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48201
        • Wayne State University/Karmanos Cancer Institute
      • Farmington Hills, Michigan, United States, 48334
        • Weisberg Cancer Treatment Center
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • Mount Clemens, Michigan, United States, 48043
        • McLaren Cancer Institute-Macomb
      • Petoskey, Michigan, United States, 49770
        • McLaren Cancer Institute-Northern Michigan
      • Saginaw, Michigan, United States, 48601
        • Ascension Saint Mary's Hospital
    • Minnesota
      • Saint Cloud, Minnesota, United States, 56303
        • Coborn Cancer Center at Saint Cloud Hospital
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Southeast Cancer Center
      • Columbia, Missouri, United States, 65212
        • University of Missouri - Ellis Fischel
      • Saint Louis, Missouri, United States, 63131
        • Missouri Baptist Medical Center
    • Nebraska
      • Kearney, Nebraska, United States, 68847
        • CHI Health Good Samaritan
    • Nevada
      • Reno, Nevada, United States, 89502
        • Renown Regional Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Basking Ridge
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Bergen
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • University of New Mexico Cancer Center
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Commack
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10032
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
      • New York, New York, United States, 10065
        • NYP/Weill Cornell Medical Center
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Syracuse, New York, United States, 13210
        • State University of New York Upstate Medical University
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Nassau
    • North Carolina
      • Albemarle, North Carolina, United States, 28002
        • Atrium Health Stanly/LCI-Albemarle
      • Asheville, North Carolina, United States, 28801
        • Mission Hospital Inc-Memorial Campus
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Lineberger Comprehensive Cancer Center
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center/Levine Cancer Institute
      • Charlotte, North Carolina, United States, 28262
        • Atrium Health University City/LCI-University
      • Charlotte, North Carolina, United States, 28211
        • Levine Cancer Institute-SouthPark
      • Charlotte, North Carolina, United States, 28277
        • Levine Cancer Institute-Ballantyne
      • Charlotte, North Carolina, United States, 28210
        • Atrium Health Lincoln/LCI-Lincoln
      • Charlotte, North Carolina, United States, 28262
        • Levine Cancer Institute-Mallard Creek
      • Concord, North Carolina, United States, 28025
        • Atrium Health Cabarrus/LCI-Concord
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Monroe, North Carolina, United States, 28112
        • Atrium Health Union/LCI-Union
      • Shelby, North Carolina, United States, 28150
        • Atrium Health Cleveland/LCI-Cleveland
      • Supply, North Carolina, United States, 28462
        • NHRMC Radiation Oncology - Supply
      • Wilmington, North Carolina, United States, 28401
        • New Hanover Regional Medical Center/Zimmer Cancer Center
      • Wilmington, North Carolina, United States, 28401
        • NHRMC Radiation Oncology - 16th Street
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Sanford Roger Maris Cancer Center
      • Fargo, North Dakota, United States, 58122
        • Sanford Broadway Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati/Barrett Cancer Center
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • Providence Saint Vincent Medical Center
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Bethlehem, Pennsylvania, United States, 18015
        • Saint Luke's University Hospital-Bethlehem Campus
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Pottstown, Pennsylvania, United States, 19464
        • Pottstown Hospital
      • West Reading, Pennsylvania, United States, 19611
        • Reading Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System Cancer Institute-Faris
      • Greenville, South Carolina, United States, 29615
        • Greenville Health System Cancer Institute-Eastside
      • Rock Hill, South Carolina, United States, 29732
        • Levine Cancer Institute-Rock Hill
      • Seneca, South Carolina, United States, 29672
        • Greenville Health System Cancer Institute-Seneca
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, United States, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center Oncology Clinic
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University/Ingram Cancer Center
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute/University of Utah
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Cancer Center
      • Fairfax, Virginia, United States, 22031
        • IMG Hematology Oncology 8501
      • Fairfax, Virginia, United States, 22031
        • IMG Hematology Oncology 8505
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Edwards Comprehensive Cancer Center
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Healthcare
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics
      • Waukesha, Wisconsin, United States, 53188
        • UW Cancer Center at ProHealth Care

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmation of radiographic stage as borderline resectable disease by real-time Alliance central radiographic review
  • No prior chemotherapy or radiation for pancreatic cancer
  • No definitive resection of pancreatic cancer
  • Chronic concomitant treatment with strong inhibitors of cytochrome p450, family 3, subfamily a, polypeptide 4 gene (CYP3A4) is not allowed on this study; patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study
  • Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug 14 days prior to the start of study treatment
  • No grade >= 2 neuropathy
  • No known Gilbert's syndrome or known homozygosity for UGAT1A1*28 polymorphism
  • No uncontrolled gastric ulcer disease (grade 3 gastric ulcer disease) within 28 days of registration
  • Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Creatinine =< 1.5 x upper limit of normal (ULN) or
  • Calculated (calc.) creatinine clearance > 45 mL/min
  • Total bilirubin =< 2.0 mg/dL
  • Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =< 2.5 X upper limit of normal (ULN)

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
Intervention / Treatment
Experimental: mFOLFIRINOX + surgery + FOLFOX
Patients receive 8 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.
oxaliplatin IV, irinotecan IV, leucovorin IV and 5-FU IV
oxaliplatin IV, leucovorin IV and 5-FU IV
Experimental: mFOLFIRINOX + radiation + surgery + FOLFOX
Patients receive 7 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients receive radiation therapy then undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.
oxaliplatin IV, irinotecan IV, leucovorin IV and 5-FU IV
oxaliplatin IV, leucovorin IV and 5-FU IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) Rate
Time Frame: 18 months
Defined as the percentage of patients who are alive at 18 months after randomization divided by the total number of evaluable patients in each arm. An evaluable patient is defined as any patient who signed informed consent, deemed eligible by central review and received any protocol-defined treatment. 95% confidence interval will be estimated based on standard method. Chi-squared test (or Fisher's exact test if the data in contingency table is sparse) will be used to compare 18 month OS rates among treatment arms. OS within each arm will be summarized by Kaplan-Meier method. Median, 1-year and 2-year rates will be estimated based on Kaplan-Meier curves.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Residual Tumor (R)0 Resection Rate
Time Frame: 24 months
Defined as the percentage of patients in whom an achieved R0 resection was achieved during surgery.
24 months
Event-free Survival
Time Frame: 4 years and 7 months
Defined as time from randomization to the first documentation of event where events considered are 1) disease progression, per RECIST, prior to surgery, 2) surgery with R2 resection, 3) recurrent disease following surgery, or 4) death due to any cause. Will be estimated using the method of Kaplan-Meier in each arm and compared between treatment groups using the log-rank test. The correlation between pathologic complete response (pCR) status and event-free survival time will be assessed by Cox model with landmark approach.
4 years and 7 months
Pathologic Complete Rate (pCR) Rate
Time Frame: 24 months
Defined as the percentage of patients in whom a pCR was confirmed by histopathologic review of the surgical specimen. Chi-square test (or Fisher's exact test if the data in contingency table is sparse) will be used to compare pCR resection rate between two treatment arms. Sensitivity analysis will be conducted among patients in cohort 1) and cohort 2). The association between pCR rate and OS/progression free survival (PFS) will be assessed by log-rank test and Cox model.
24 months
Incidence of Adverse Events Assessed Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4 and the Patient-Reported Outcomes Version of the CTCAE
Time Frame: 1 year
Overall adverse event rates will be compared between treatment groups using Chi-square test (or Fisher's exact test if the data in contingency table is sparse).
1 year

Collaborators and Investigators

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

Investigators

  • Study Chair: Matthew Katz, MD, FACS, The University of Texas MD Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

December 1, 2016

Primary Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

July 14, 2016

First Submitted That Met QC Criteria

July 18, 2016

First Posted (Estimate)

July 20, 2016

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

April 28, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • A021501
  • NCI-2016-00456 (Registry Identifier: NCI Clinical Trial Reporting Program)

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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