Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer

June 13, 2023 updated by: Eastern Cooperative Oncology Group

A Randomized Phase II Study Of Gemcitabine Plus Radiotherapy Vs. Gemcitabine, 5-Fluorouracil And Cisplatin Followed By Radiotherapy And 5-Fluoraracil For Patients With Locally Advanced, Potentially Resectable Pancreatic Adenocarcinoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens combining chemotherapy with radiation therapy in treating patients who are undergoing surgery for locally advanced pancreatic cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the percentage of margin-free resections in patients with locally advanced, potentially resectable adenocarcinoma of the pancreas treated with gemcitabine and radiotherapy vs gemcitabine, fluorouracil, and cisplatin followed by radiotherapy and fluorouracil.
  • Compare the efficacy of these regimens, as measured by CT scan response, in these patients.
  • Compare the posttreatment fibrosis in resected specimens of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Compare the duration of objective response in patients treated with these regimens.
  • Compare the disease-free and overall survival of patients treated with these regimens.
  • Compare the effect of these regimens and disease recurrence on CA 19-9 values in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to superior mesenteric vein (SMV)/portal vein (PV) occlusion (yes vs no), SMV/PV/superior mesenteric artery/hepatic artery abutment or narrowing (yes vs no), prior exploration (yes vs no), and whether deemed to require preoperative therapy due to other factors (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo radiotherapy once daily 5 days a week for 6 weeks. Patients receive gemcitabine IV over 50 minutes once weekly for 6 weeks during radiotherapy. Patients undergo surgical resection 4-6 weeks after completion of chemoradiotherapy.

Maintenance therapy (4-8 weeks after completion of surgery): Patients receive gemcitabine IV over 100 minutes once weekly for 2 weeks. Treatment repeats every 3 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.

  • Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 5, 29, and 33; cisplatin IV over 60 minutes on days 1-5 and 29-33; and fluorouracil IV continuously on days 1-4 and 29-32. Patients also receive filgrastim (G-CSF) subcutaneously (SC) daily on days 6-15 and 34-43 and epoetin alfa SC weekly on weeks 1-9. After completion of chemotherapy, patients undergo radiotherapy once daily 5 days a week for 6 weeks. Patients receive fluorouracil IV continuously daily during radiotherapy. Patients undergo surgical resection 4-6 weeks after completion of chemoradiotherapy.

Maintenance therapy (4-8 weeks after completion of surgery): Patients receive gemcitabine IV over 100 minutes once weekly for 2 weeks. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 80-160 patients (40-80 per treatment arm) will be accrued for this study.

Study Type

Interventional

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

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • CCOP - Mayo Clinic Scottsdale Oncology Program
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8032
        • Yale Comprehensive Cancer Center
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Lynn Regional Cancer Center of Boca Raton Community Hospital
      • Gainesville, Florida, United States, 32610
        • University of Florida Shands Cancer Center
      • Jacksonville, Florida, United States, 32224-9980
        • Mayo Clinic - Jacksonville
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital - Atlanta
      • Decatur, Georgia, United States, 30033
        • Veterans Affairs Medical Center - Atlanta (Decatur)
      • Macon, Georgia, United States, 31208
        • Medical Center of Central Georgia
    • Illinois
      • Aurora, Illinois, United States, 60507
        • Rush-Copley Cancer Care Center
      • Bloomington, Illinois, United States, 61701
        • St. Joseph Medical Center
      • Canton, Illinois, United States, 61520
        • Graham Hospital
      • Carthage, Illinois, United States, 62321
        • Memorial Hospital
      • Chicago, Illinois, United States, 60625
        • Swedish Covenant Hospital
      • Chicago, Illinois, United States, 60611
        • Hematology and Oncology Associates
      • Chicago, Illinois, United States, 60611
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
      • Chicago, Illinois, United States, 60611
        • Veterans Affairs Medical Center - Lakeside Chicago
      • Chicago, Illinois, United States, 60616
        • Mercy Hospital and Medical Center
      • Effingham, Illinois, United States, 62401
        • St. Anthony's Memorial Hospital
      • Eureka, Illinois, United States, 61530
        • Eureka Hospital
      • Evanston, Illinois, United States, 60201
        • Evanston Northwestern Health Care - Evanston Hospital
      • Galesburg, Illinois, United States, 61401
        • Galesburg Cottage Hospital
      • Galesburg, Illinois, United States, 61401
        • Galesburg Clinic
      • Galesburg, Illinois, United States, 61401
        • InterCommunity Cancer Center of Western Illinois
      • Havana, Illinois, United States, 62644
        • Mason District Hospital
      • Hopedale, Illinois, United States, 61747
        • Hopedale Medical Complex
      • Joliet, Illinois, United States, 60432
        • Midwest Center for Hematology/Oncology
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology Hematology Associates, Limited - West
      • Kewanee, Illinois, United States, 61443
        • Kewanee Hospital
      • Lake Forest, Illinois, United States, 60045
        • Deerpath Medical Associates
      • Libertyville, Illinois, United States, 60048
        • North Shore Oncology and Hematology Associates, Limited - Libertyville
      • Macomb, Illinois, United States, 61455
        • Mcdonough District Hospital
      • Niles, Illinois, United States, 60714
        • Northwest Medical Specialist P.C.
      • Normal, Illinois, United States, 61761
        • Bromenn Regional Medical Center
      • Normal, Illinois, United States, 61761
        • Community Cancer Center
      • Ottawa, Illinois, United States, 61350
        • Community Hospital of Ottawa
      • Ottawa, Illinois, United States, 61350
        • Oncology Hematology Associates of Central Illinois - Ottawa
      • Pekin, Illinois, United States, 61554
        • Cancer Treatment Center at Pekin Hospital
      • Peoria, Illinois, United States, 61614
        • Proctor Hospital
      • Peoria, Illinois, United States, 61603
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, United States, 61637
        • OSF St. Francis Medical Center
      • Peoria, Illinois, United States, 61615
        • CCOP - Illinois Oncology Research Association
      • Peoria, Illinois, United States, 61615
        • Oncology/Hematology Associates of Central Illinois, P.C.
      • Peru, Illinois, United States, 61354
        • Illinois Valley Community Hospital
      • Princeton, Illinois, United States, 61356
        • Perry Memorial Hospital
      • Rockford, Illinois, United States, 61104
        • Swedish American Hospital
      • Skokie, Illinois, United States, 60076
        • Hematology Oncology Associates - Skokie
      • Skokie, Illinois, United States, 60076
        • Hematology/Oncology of the North Shore
      • Skokie, Illinois, United States, 60077
        • Midwest Cancer Research Group, Incorporated
      • Spring Valley, Illinois, United States, 61362
        • St. Margaret's Hospital
      • Spring Valley, Illinois, United States, 61362
        • Valley Cancer Center
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center at Carle Foundation Hospital
      • Urbana, Illinois, United States, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Elkhart, Indiana, United States, 46515
        • Elkhart General Hospital
      • La Porte, Indiana, United States, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • Michigan City, Indiana, United States, 46360
        • Saint Anthony Memorial Health Centers
      • Plymouth, Indiana, United States, 46544
        • Saint Joseph Regional Medical Center - Plymouth Campus
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, United States, 46601
        • CCOP - Northern Indiana CR Consortium
    • Iowa
      • Ames, Iowa, United States, 50010
        • McFarland Clinic, P.C.
      • Sioux City, Iowa, United States, 51101-1733
        • Siouxland Regional Cancer Center
      • Sioux City, Iowa, United States, 51104
        • St. Luke's Regional Medical Center
      • Sioux City, Iowa, United States, 51104
        • Mercy Medical Center - Sioux City
      • Sioux City, Iowa, United States, 51101
        • Siouxland Hematology-Oncology Associates
    • Kansas
      • Chanute, Kansas, United States, 66720
        • Cancer Center of Kansas - Chanute
      • Dodge City, Kansas, United States, 67801
        • Cancer Center of Kansas - Dodge City
      • El Dorado, Kansas, United States, 67042
        • Cancer Center of Kansas, P.A. - El Dorado
      • Kingman, Kansas, United States, 67068
        • Cancer Center of Kansas - Kingman
      • Liberal, Kansas, United States, 67901
        • Southwest Medical Center
      • Newton, Kansas, United States, 67114
        • Cancer Center of Kansas - Newton
      • Ottawa, Kansas, United States, 66067
        • Cancer Center of Kansas - Ottawa
      • Parsons, Kansas, United States, 67357
        • Cancer Center of Kansas, P.A. - Parsons
      • Pratt, Kansas, United States, 67124
        • Pratt Cancer Center of Kansas
      • Salina, Kansas, United States, 67042
        • Cancer Center of Kansas - Salina
      • Wellington, Kansas, United States, 67152
        • Cancer Center of Kansas - Wellington
      • Wichita, Kansas, United States, 67214
        • Wesley Medical Center
      • Wichita, Kansas, United States, 67214
        • CCOP - Wichita
      • Wichita, Kansas, United States, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Wichita, Kansas, United States, 67203
        • Associates In Womens Health
      • Wichita, Kansas, United States, 67208
        • Cancer Center of Kansas, P.A.
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas, P.A. - Wichita
      • Winfield, Kansas, United States, 67156
        • Cancer Center of Kansas - Winfield
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70806
        • Baton Rouge General Regional Cancer Center
      • Baton Rouge, Louisiana, United States, 70809
        • Mary Bird Perkins Cancer Center - Baton Rouge
      • New Orleans, Louisiana, United States, 70112
        • MBCCOP - LSU Health Sciences Center
      • New Orleans, Louisiana, United States, 70112
        • Cancer Center at Medical Center of Louisiana - New Orleans
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Greenfield, Massachusetts, United States, 01301
        • Franklin Medical Center
      • Holyoke, Massachusetts, United States, 01040
        • Holyoke Medical Center, Incorporated
      • Springfield, Massachusetts, United States, 01199
        • Baystate Regional Cancer Program at D'Amour Center for Cancer Care
      • Westfield, Massachusetts, United States, 01085
        • Noble Hospital
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
        • MeritCare Clinic - Bemidji
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, United States, 55432
        • Mercy and Unity Cancer Center at Mercy and Unity Hospitals
      • Hutchinson, Minnesota, United States, 55350
        • Hutchinson Area Health Care
      • Litchfield, Minnesota, United States, 55355
        • Meeker County Memorial Hospital
      • Maplewood, Minnesota, United States, 55109
        • St. John's Hospital
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center - Minneapolis
      • Minneapolis, Minnesota, United States, 55407
        • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
      • Robbinsdale, Minnesota, United States, 55422
        • Hubert H. Humphrey Cancer Center at North Memorial Medical Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic
      • Saint Paul, Minnesota, United States, 55102
        • St. Joseph's Hospital
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Saint Paul, Minnesota, United States, 55101
        • Cancer Care Center at Regions Hospital
      • Shakopee, Minnesota, United States, 55379
        • Saint Francis Cancer Center
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
      • Woodbury, Minnesota, United States, 55125
        • Woodwinds Hospital
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • CCOP - Northern New Jersey
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Medcenter One Health System
      • Bismarck, North Dakota, United States, 58501
        • Mid Dakota Clinic, P.C.
      • Bismarck, North Dakota, United States, 58501
        • Bismarck Cancer Center
      • Bismarck, North Dakota, United States, 58501
        • St. Alexius Medical Center
      • Fargo, North Dakota, United States, 58122
        • CCOP - MeritCare Hospital
      • Fargo, North Dakota, United States, 58122
        • MeritCare Medical Group
    • Ohio
      • Boardman, Ohio, United States, 44512
        • St. Elizabeth Boardman Cancer Center
      • Lima, Ohio, United States, 45801
        • St. Rita's Medical Center
      • Warren, Ohio, United States, 44484
        • St. Joseph Health Care Center
      • Youngstown, Ohio, United States, 44510
        • St. Elizabeth Cancer Center at St. Elizabeth Health Center - Youngstown
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's Hospital Cancer Center
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Lewistown, Pennsylvania, United States, 17044
        • Lewistown Hospital
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Fox Chase Cancer Center
      • State College, Pennsylvania, United States, 16803
        • Mount Nittany Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Medical X-Ray Center
      • Sioux Falls, South Dakota, United States, 57104
        • Sioux Valley Hospital and University of South Dakota Medical Center
      • Sioux Falls, South Dakota, United States, 57105
        • Avera McKennan Hospital and University Health Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Cancer Center
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital
      • Green Bay, Wisconsin, United States, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital
      • Green Bay, Wisconsin, United States, 54301
        • St. Vincent Hospital
      • Green Bay, Wisconsin, United States, 54303
        • St. Mary's Hospital Medical Center
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
      • Marinette, Wisconsin, United States, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center

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

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the pancreas

    • No adenosquamous cancers or adenocarcinoma associated with cystic mucinous neoplasms
    • Locally advanced disease that is potentially resectable, previously explored and considered unresectable, or deemed to require preoperative treatment for other reasons
    • Primary cancer in the head, body, or tail of pancreas
  • Measurable disease
  • No 360 degree encirclement of the superior mesenteric artery, hepatic artery, or celiac axis
  • No metastases by CT scan and laparoscopy (if prior surgery, only CT scan required)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute granulocyte count greater than 2,000/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic

  • Bilirubin less than 2 mg/dL (unless secondary to bile duct blockage by tumor)
  • Biliary obstruction by tumor requires biliary stent at least 9 French or biliary bypass before therapy

Renal

  • Creatinine less than 1.7 mg/dL OR
  • Creatinine clearance greater than 60 mL/min

Other

  • No other malignancy within the past 3 years except nonmelanoma skin cancer
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for this disease

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to pancreas

Surgery

  • Not specified

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percentage of margin-free resections produced by each program

Secondary Outcome Measures

Outcome Measure
Toxicity
Overall survival
Disease-free survival
Duration of objective response
Efficacy as measured by CT scan response
Post-treatment fibrosis in the resected specimens
Effect of therapy and recurrence on CA19-9 values

Collaborators and Investigators

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

Sponsor

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: John Parker Hoffman, MD, Fox Chase 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.

General Publications

  • Landry JC, Catalano P, Hoffman J, et al.: ECOG 1200: a randomized phase II trial of gemcitabine plus radiotherapy vs gemcitabine, 5-fluorouracil and cisplatin followed by radiotherapy and 5-fluorouracil in patients with locally advanced, potentially resectable pancreatic adenocarcinoma. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2111, S272, 2006.

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)

October 13, 2003

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

November 12, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimated)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000258056
  • E1200

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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