Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer

A Randomized Phase III Study Of Gemcitabine In Combination With Radiation Therapy Versus Gemcitabine Alone In Patients With Localized, Unresectable Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy work in 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. It is not yet known whether gemcitabine is more effective with or without radiation therapy in treating pancreatic cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of gemcitabine with or without radiation therapy in treating patients who have locally advanced, unresectable pancreatic cancer.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: Gemcitabine; Radiation: radiation therapy

Detailed Description

OBJECTIVES:

• Compare the overall survival and progression-free of patients with locally advanced, unresectable pancreatic cancer treated with gemcitabine with or without radiotherapy.
• Compare the objective response rate in patients treated with these regimens.
• Compare the toxicity of these regimens in these patients.
• Compare the quality of life (QOL) of patients treated with these regimens.
• Determine the effect of gemcitabine and radiotherapy on the QOL of patients with improved objective response rate and progression-free and overall survival.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs. 1) and weight loss within the past 6 months (less than 10% vs. 10% or more). Patients are randomized to 1 of 2 treatment arms.

Arm I (Gemcitabine alone):

• Induction: Patients receive gemcitabine intravenously (IV) over 30-60 minutes once weekly for 6 weeks followed by 1 week of rest.
• Consolidation: After the 1 week of rest, patients receive gemcitabine IV once weekly for 3 weeks. Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.

Arm II (Gemcitabine with radiotherapy):

• Induction: Patients receive gemcitabine IV over 30-60 minutes once weekly for 6 weeks beginning on day 1. Patients also undergo concurrent radiotherapy 5 days a week for 5.5 weeks beginning on day 1.
• Consolidation: Approximately 4 weeks after completion of radiotherapy, patients receive gemcitabine IV over 30-60 minutes once weekly for 3 weeks. Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, week 6, week 15 (for arm II), week 16 (for arm I), and 9 months.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year. Patients who receive treatment beyond 3 years are followed for survival.

ACCRUAL: 74 patients were accrued for this study.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 3

Contacts and Locations

Study Locations

• South Africa
  • Pretoria, 0001, South Africa
    • Pretoria Academic Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner Good Samaritan Medical Center
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Saint Joseph's Mercy Cancer Center
  • California
    • Fresno, California, United States, 93720
      • California Cancer Center - Woodward Park Office
    • Modesto, California, United States, 95355
      • Memorial Medical Center Cancer Services
    • Modesto, California, United States, 95350
      • Doctors Medical Center
  • Colorado
    • Greeley, Colorado, United States, 80631
      • North Colorado Medical Center
    • Loveland, Colorado, United States, 80539
      • McKee Medical Center
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
    • New Britain, Connecticut, United States, 06050
      • New Britain General Hospital
    • New Haven, Connecticut, United States, 06520-8032
      • Yale Comprehensive Cancer Center at Yale University School of Medicine
    • Norwich, Connecticut, United States, 06360
      • William W. Backus Hospital
  • Florida
    • Daytona Beach, Florida, United States, 32115
      • Halifax Medical Center
    • Gainesville, Florida, United States, 32610
      • University of Florida Shands Cancer Center
    • Jacksonville, Florida, United States, 32207
      • Baptist Cancer Institute - Jacksonville
    • 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)
    • Gainesville, Georgia, United States, 30501
      • Northeast Georgia Medical Center
    • Savannah, Georgia, United States, 31405
      • Cancer Care and Research Pavilion at St. Joseph's/Candler
    • Valdosta, Georgia, United States, 31603
      • Pearlman Comprehensive Cancer Center at South Georgia Medical Center
  • 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, 60616
      • Mercy Hospital and Medical Center
    • Effingham, Illinois, United States, 62401
      • St. Anthony's Memorial Hospital
    • Eureka, Illinois, United States, 61530
      • Eureka Community 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
    • Hinsdale, Illinois, United States, 60521
      • Hinsdale Hematology Oncology Associates
    • 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
    • Kankakee, Illinois, United States, 60901
      • Provena St. Mary's Wasser Regional Cancer Center - Kankakee
    • Kewanee, Illinois, United States, 61443
      • Kewanee Hospital
    • La Grange, Illinois, United States, 60525
      • La Grange Memorial 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, PC
    • 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
    • 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, 60077
      • Midwest Cancer Research Group, Incorporated
    • Skokie, Illinois, United States, 60076
      • Hematology/Oncology of the North Shore at Gross Point Medical Center
    • 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
    • Fort Wayne, Indiana, United States, 46815
      • Fort Wayne Medical Oncology and Hematology
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Cancer Center
    • Indianapolis, Indiana, United States, 46202
      • William N. Wishard Memorial 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
    • South Bend, Indiana, United States, 46601
      • Memorial Hospital of South Bend
    • South Bend, Indiana, United States, 46601
      • CCOP - Northern Indiana CR Consortium
    • South Bend, Indiana, United States, 46617
      • Saint Joseph Regional Medical Center
  • Iowa
    • Ames, Iowa, United States, 50010
      • McFarland Clinic, P.C.
    • Davenport, Iowa, United States, 52803
      • Genesis Regional Cancer Center at Genesis Medical Center
    • Des Moines, Iowa, United States, 50309
      • CCOP - Iowa Oncology Research Association
    • Des Moines, Iowa, United States, 50309
      • John Stoddard Cancer Center at Iowa Methodist Medical Center
    • Des Moines, Iowa, United States, 50309
      • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
    • Des Moines, Iowa, United States, 50314
      • Medical Oncology and Hematology Associates at Mercy Cancer Center
    • Des Moines, Iowa, United States, 50314
      • Mercy Cancer Center at Mercy Medical Center - Des Moines
    • Des Moines, Iowa, United States, 50316
      • John Stoddard Cancer Center at Iowa Lutheran Hospital
    • Des Moines, Iowa, United States, 50307
      • Mercy Capitol Hospital
    • Mason City, Iowa, United States, 50401
      • Mercy Cancer Center at Mercy Medical Center - North Iowa
    • Onawa, Iowa, United States, 51040
      • Burgess Health Center
    • Ottumwa, Iowa, United States, 52501
      • Ottumwa Regional Health Center 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 at June E. Nylen Cancer Center
    • West Des Moines, Iowa, United States, 50266
      • Medical Oncology and Hematology Associates - West Des Moines
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Central Baptist Hospital
  • 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
      • Medical Center of Louisiana - New Orleans
  • Maryland
    • Baltimore, Maryland, United States, 21287-8936
      • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • TUFTS - New England Medical Center
  • Michigan
    • Adrian, Michigan, United States, 49221
      • Hickman Cancer Center at Bixby Medical Center
    • Escanaba, Michigan, United States, 49431
      • Green Bay Oncology, Limited - Escanaba
    • Iron Mountain, Michigan, United States, 49801
      • Green Bay Oncology, Limited - Iron Mountain
    • Kalamazoo, Michigan, United States, 49007
      • West Michigan Cancer Center
    • Kalamazoo, Michigan, United States, 49007
      • Bronson Methodist Hospital
    • Kalamazoo, Michigan, United States, 49001
      • Borgess Medical Center
    • Lambertville, Michigan, United States, 48144
      • Haematology-Oncology Associates of Ohio and Michigan, P.C.
    • Monroe, Michigan, United States, 48162
      • Mercy Memorial Hospital System
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital - Royal Oak Campus
    • Saint Joseph, Michigan, United States, 49085
      • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
  • Minnesota
    • Burnsville, Minnesota, United States, 55337
      • Fairview Ridges Hospital
    • Coon Rapids, Minnesota, United States, 55433
      • Mercy and Unity Cancer Center at Mercy Hospital
    • Duluth, Minnesota, United States, 55805
      • CCOP - Duluth
    • Duluth, Minnesota, United States, 55805
      • St. Mary's - Duluth Clinic Cancer Center
    • Duluth, Minnesota, United States, 55805
      • Miller-Dwan Medical Center
    • Edina, Minnesota, United States, 55435
      • Fairview Southdale Hospital
    • Fridley, Minnesota, United States, 55432
      • Mercy and Unity Cancer Center at Unity Hospital
    • Minneapolis, Minnesota, United States, 55403
      • 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 Cloud, Minnesota, United States, 56303
      • CentraCare Clinic - River Campus
    • Saint Louis Park, Minnesota, United States, 55416
      • CCOP - Metro-Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • Park Nicollet Health Services
    • Saint Paul, Minnesota, United States, 55102
      • United Hospital
    • Waconia, Minnesota, United States, 55387
      • Ridgeview Medical Center
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Ellis Fischel Cancer Center at University of Missouri - Columbia
    • Springfield, Missouri, United States, 65804
      • St. John's Regional Health Center
    • Springfield, Missouri, United States, 65807
      • Hulston Cancer Center at Cox Medical Center South
  • Montana
    • Billings, Montana, United States, 59101
      • CCOP - Montana Cancer Consortium
    • Great Falls, Montana, United States, 59405
      • Great Falls Clinic
  • Nebraska
    • Kearney, Nebraska, United States, 68847
      • Good Samaritan Health Systems
    • Lincoln, Nebraska, United States, 68502
      • Bryan LGH Medical Center West
    • Lincoln, Nebraska, United States, 68510
      • Cancer Resource Center - Lincoln
    • Omaha, Nebraska, United States, 68131
      • Creighton University Medical Center
    • Omaha, Nebraska, United States, 68106
      • CCOP - Missouri Valley Cancer Consortium
    • Omaha, Nebraska, United States, 68122
      • Immanuel Medical Center
    • Omaha, Nebraska, United States, 68124
      • Bergan Mercy Medical Center
    • Omaha, Nebraska, United States, 68114
      • Methodist Cancer Center at Methodist Hospital - Omaha
    • Papillion, Nebraska, United States, 68046
      • Midlands Cancer Center at Midlands Community Hospital
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • CCOP - Nevada Cancer Research Foundation
  • New Jersey
    • East Orange, New Jersey, United States, 07018-1095
      • Veterans Affairs Medical Center - East Orange
    • Flemington, New Jersey, United States, 08822
      • Hunterdon Regional Cancer Center at Hunterdon Medical Center
    • Marlton, New Jersey, United States, 08053
      • Fox Chase Virtua Health Cancer Program - Marlton
    • Red Bank, New Jersey, United States, 07701
      • Booker Cancer Center at Riverview Medical Center
    • Somers Point, New Jersey, United States, 08244
      • Shore Memorial Hospital - Somers Point
    • Toms River, New Jersey, United States, 08755
      • Community Regional Cancer Center at Community Medical Center
  • New York
    • Cooperstown, New York, United States, 13326
      • Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital
  • North Carolina
    • Goldsboro, North Carolina, United States, 27534
      • Wayne Memorial Hospital, Incorporated
    • Greenville, North Carolina, United States, 27858
      • Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
    • Wilmington, North Carolina, United States, 28401
      • Zimmer Cancer Center at New Hanover Regional Medical Center
    • Wilson, North Carolina, United States, 27893
      • Wilson Medical Center
    • Winston-Salem, North Carolina, United States, 27103
      • Forsyth Regional Cancer Center at Forsyth Medical Center
  • North Dakota
    • 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
      • Cancer Care Center at Medcenter One Hospital
    • Bismarck, North Dakota, United States, 58501
      • St. Alexius Medical Center
    • Minot, North Dakota, United States, 58701
      • Trinity Cancer Care Center
  • Ohio
    • Boardman, Ohio, United States, 44512
      • St. Elizabeth Boardman Cancer Center
    • Canton, Ohio, United States, 44710
      • Aultman Hospital Cancer Center at Aultman Health Foundation
    • Canton, Ohio, United States, 44708
      • University Hospitals Ireland Cancer Center at Mercy Medical Center
    • Cleveland, Ohio, United States, 44109
      • MetroHealth's Cancer Care Center at MetroHealth Medical Center
    • Cleveland, Ohio, United States, 44106
      • Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
    • Findlay, Ohio, United States, 45840
      • Blanchard Valley Medical Associates
    • Fremont, Ohio, United States, 43420
      • Fremont Memorial Hospital
    • Lima, Ohio, United States, 45804
      • Lima Memorial Hospital
    • Lima, Ohio, United States, 45801
      • St. Rita's Medical Center
    • Maumee, Ohio, United States, 43537
      • St. Luke's Hospital
    • Oregon, Ohio, United States, 43616
      • St. Charles Mercy Hospital
    • Sandusky, Ohio, United States, 44870
      • Firelands Regional Medical Center
    • Sylvania, Ohio, United States, 43560
      • Promedica Cancer Center at Flower Hospital
    • Tiffin, Ohio, United States, 44883
      • Mercy Hospital of Tiffin
    • Toledo, Ohio, United States, 43608
      • St. Vincent Mercy Medical Center
    • Toledo, Ohio, United States, 43606
      • Toledo Hospital
    • Toledo, Ohio, United States, 43623
      • Toledo Clinic, Incorporated - Main Clinic
    • Toledo, Ohio, United States, 43623
      • CCOP - Toledo Community Hospital
    • Toledo, Ohio, United States, 43614
      • Medical College of Ohio Cancer Institute
    • Warren, Ohio, United States, 44484
      • St. Joseph Health Care Center
    • Wauseon, Ohio, United States, 43567
      • Fulton County Health Center
    • Youngstown, Ohio, United States, 44510
      • St. Elizabeth Cancer Center at St. Elizabeth Health Center - Youngstown
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Natalie Warren Bryant Cancer Center at St. Francis Hospital
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Bryn Mawr Hospital
    • Drexel Hill, Pennsylvania, United States, 19026
      • Delaware County Regional Cancer Center at Delaware County Memorial Hospital
    • Hershey, Pennsylvania, United States, 17033-0850
      • Penn State Cancer Institute at Milton S. Hershey Medical Center
    • Lancaster, Pennsylvania, United States, 17604
      • Lancaster General Hospital
    • Lewistown, Pennsylvania, United States, 17044
      • Lewistown Hospital
    • Paoli, Pennsylvania, United States, 19301
      • Paoli Memorial Hospital
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Cancer Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
    • Phoenixville, Pennsylvania, United States, 19460
      • Phoenixville Hospital
    • Pittsburgh, Pennsylvania, United States, 15240
      • Veterans Affairs Medical Center - Pittsburgh
    • Pittsburgh, Pennsylvania, United States, 15213
      • Hillman Cancer Center at University of Pittsburgh Cancer Institute
    • Reading, Pennsylvania, United States, 19604
      • St. Joseph Medical Center
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie Medical Center - Sayre
    • Scranton, Pennsylvania, United States, 18510
      • Hematology and Oncology Associates
    • State College, Pennsylvania, United States, 16803
      • Mount Nittany Medical Center
    • West Chester, Pennsylvania, United States, 19380
      • Chester County Hospital
    • West Grove, Pennsylvania, United States, 19390
      • Jennersville Regional Hospital
    • West Reading, Pennsylvania, United States, 19612
      • Reading Hospital and Medical Center
    • Wynnewood, Pennsylvania, United States, 19096
      • CCOP - MainLine Health
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Cancer Center at Lankenau Hospital
  • South Dakota
    • 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
    • Sioux Falls, South Dakota, United States, 57105
      • Medical X-Ray Center, P. C.
  • Tennessee
    • Knoxville, Tennessee, United States, 37916
      • Thompson Cancer Survival Center
    • Knoxville, Tennessee, United States, 37920
      • Baptist Regional Cancer Center at Baptist Hospital of East Tennessee
  • Texas
    • Laredo, Texas, United States, 78041
      • Doctor's Hospital of Laredo
    • Lubbock, Texas, United States, 79410
      • Joe Arrington Cancer Research and Treatment Center
    • Tyler, Texas, United States, 75701
      • East Texas Medical Center Cancer Institute
  • Utah
    • Murray, Utah, United States, 84107
      • Cottonwood Hospital Medical Center
    • Ogden, Utah, United States, 84403
      • McKay-Dee Hospital Center
    • Provo, Utah, United States, 84603
      • Utah Valley Regional Medical Center - Provo
    • Saint George, Utah, United States, 84770
      • Dixie Regional Medical Center
    • Salt Lake City, Utah, United States, 84143
      • LDS Hospital
    • Salt Lake City, Utah, United States, 84106
      • Utah Cancer Specialists at UCS Cancer Center
  • Virginia
    • Charlottesville, Virginia, United States, 22901
      • Martha Jefferson Hospital Cancer Care Center
    • Richmond, Virginia, United States, 23226
      • Bon Secours Cancer Care at St. Mary's Hospital
  • Washington
    • Seattle, Washington, United States, 98114
      • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
    • Huntington, West Virginia, United States, 25701
      • Marshall University Medical Center
  • Wisconsin
    • Fond Du Lac, Wisconsin, United States, 54935
      • Central Wisconsin Cancer Program at Agnesian HealthCare
    • 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, 54303
      • St. Mary's Hospital Medical Center
    • Green Bay, Wisconsin, United States, 54301
      • St. Vincent Hospital Regional Cancer Center
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
    • Manitowoc, Wisconsin, United States, 54221
      • Cancer Care Center at Holy Family Memorial Medical Center
    • Marinette, Wisconsin, United States, 54143
      • Bay Area Cancer Care Center at Bay Area Medical Center
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Clinic - Marshfield Center
    • Oconto Falls, Wisconsin, United States, 54154
      • Green Bay Oncology, Limited - Oconto Falls
    • Sturgeon Bay, Wisconsin, United States, 54235
      • Green Bay Oncology, Limited - Sturgeon Bay
    • Wausau, Wisconsin, United States, 54401
      • University of Wisconsin Cancer Center at Aspirus Wausau Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas

  • Locally advanced or regional (encompassable within the same radiotherapy portals)
  • Adenosquamous cancers are allowed
• Unresectable disease
• Measurable and/or non-measurable disease as determined by computed tomography (CT) scan or magnetic resonance imaging (MRI), which must be performed within 4 weeks prior to randomization.
• Age>=18
• ECOG Performance status of 0-1
• Life expectancy >= 12 weeks

• Adequate bone marrow reserve,liver and renal function within 2 weeks of randomization:

  • Absolute granulocyte count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin less than 3 mg/dL (unless secondary to biliary obstruction or cholangitis)
  • Serum glutamic-oxaloacetic (AST) less than 5 times upper limit of normal (ULN)
  • Albumin greater than 2.5 g/dL
  • Creatinine no greater than 1.5 times ULN
• Fertile patients must use effective contraception
• Willing and able to attend follow-up visits
• Concurrent enrollment on protocol ECOG-E1Y03 allowed
• More than 4 weeks since prior investigational agents

Exclusion Criteria:

• Candidate for surgical excision based on local extent of disease (e.g., T3, N1, M0)
• Stage M1 disease
• Small cell, mucinous cystadenocarcinoma, islet cell or papillary cystic histology
• Pregnant or nursing
• Active infection within within 4 weeks of randomization
• Malignancy within the past 5 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or organ-confined prostate cancer (Gleason score no greater than 7)
• History of active collagen vascular disease (i.e., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma)
• Signs or symptoms of peptic or duodenal ulcer disease
• Concurrent serious systemic disorders that are incompatible with study participation
• Prior chemotherapy for pancreatic cancer
• Prior radiotherapy
• Concurrent intensity modulated radiotherapy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gemcitabine	Drug: Gemcitabine; Induction: Patients receive the first cycle of gemcitabine 1000 mg/m^2 intravenously once per week for 6 weeks followed by 1 week rest. Consolidation: Following the week of rest, treatment resume with gemcitabine 1000 mg/m^2 administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles.; Other Names: Gemzar; 2-Deoxy-2; 2-difluorocytidine monohydrochloride
Experimental: Gemcitabine + Radiation	Radiation: radiation therapy; Induction: Patients receive gemcitabine 600 mg/m^2 intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose is given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction is 180 cGy prescribed to the isocenter. The total dose of radiation is 5040 cGy given in 28 fractions over 5 1/2 weeks. Consolidation: Additional cycles of gemcitabine begin approximately 4 weeks after completion of radiation therapy.; Other Names: Gemzar; 2-Deoxy-2; 2-difluorocytidine monohydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Time	Overall survival was defined as the time from randomization (registration) to death from any cause. Patients alive at last follow-up were censored. Patients were followed every 3 months for 2 years and then every 6 months for year 3. Patients received treatment beyond 3 years were also followed for survival.	assessed every 3 months for 2 years, then every 6 months for year 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival Time	Time from randomization (registration) to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions (taking as reference the baseline sum longest diameter), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Patients were followed every 3 months for 2 years and then every 6 months for year 3. Patients who received treatment beyond 3 years were also followed for survival.	assessed every 3 months for 2 years, then every 6 months for year 3
Overall Response	Response was assessed per Response Evaluation Criteria In Solid Tumors (RECIST) by CT. Overall response included complete response (CR) and partial response (PR). CR was defined as the disappearance of all target and non-target lesions. PR was defined as CR of target lesions and persistence of one or more non-target lesions or at least a 30% decrease in the sum of the longest diameters of target lesions and non-progressive disease in the non-target lesions. The 71 eligible, treated participants were included in the analysis.	assessed at week 8, and every 3 months for 2 years, then every 6 months for year 3

Collaborators and Investigators

• Sponsor: Eastern Cooperative Oncology Group
• Collaborators: National Cancer Institute (NCI); Radiation Therapy Oncology Group
• Investigators: Study Chair: Patrick J. Loehrer, MD, Indiana University Melvin and Bren Simon Cancer Center

Publications and helpful links

General Publications

• Loehrer PJ, Powell ME, Cardenes HR, et al.: A randomized phase III study of gemcitabine in combination with radiation therapy versus gemcitabine alone in patients with localized, unresectable pancreatic cancer: E4201. [Abstract] J Clin Oncol 26 (Suppl 15): A-4506, 2008.

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2003
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: April 7, 2003
• First Submitted That Met QC Criteria: April 8, 2003
• First Posted (Estimated): April 9, 2003

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: adenocarcinoma of the pancreas; stage III pancreatic cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Gemcitabine
• Other Study ID Numbers: CDR0000278947; U10CA021115 (U.S. NIH Grant/Contract); E4201 (Other Identifier: Eastern Cooperative Oncology Group (ECOG) and Radiation Therapy Oncology Group (RTOG))