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Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer
This study has been completed.
First Received: April 7, 2003   Last Updated: May 29, 2009   History of Changes
Sponsor: Eastern Cooperative Oncology Group
Collaborators: National Cancer Institute (NCI)
Radiation Therapy Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00057876
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
 Drug: gemcitabine hydrochloride
Radiation: radiation therapy
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Randomized Phase III Study Of Gemcitabine In Combination With Radiation Therapy Versus Gemcitabine Alone In Patients With Localized, Unresectable Pancreatic Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Gemcitabine Gemcitabine hydrochloride
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival at 13, 20, 26, and 36 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Toxicity as measured by NCI CTC v2.0 [ Designated as safety issue: Yes ]
  • Quality of life as measured by Functional Assessment of Cancer Treatment-Hepatobiliary Symptom Index at baseline, 6, 15, and 16 weeks, and at 9 months [ Designated as safety issue: No ]

Study Start Date: April 2003
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Compare the progression-free and overall survival 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 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.

PROJECTED ACCRUAL: Approximately 332 patients will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the pancreas

    • Locally advanced or regional (encompassable within the same radiotherapy portals) disease
    • No M1 disease
    • Adenosquamous cancers are allowed

  • The following cellular types are not allowed:

    • Small cell
    • Mucinous cystadenocarcinoma
    • Islet cell
    • Papillary cystic neoplasms
  • Unresectable disease, defined as a tumor causing superior mesenteric vein or portal vein occlusion OR superior mesenteric artery or hepatic artery encasement
  • Must not be a candidate for surgical excision based on local extent of disease (e.g., T3, N1, M0)
  • Measurable and/or nonmeasurable disease by CT scan or MRI

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute granulocyte count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin less than 3 mg/dL (unless secondary to biliary obstruction or cholangitis)
  • AST less than 5 times upper limit of normal (ULN)
  • Albumin greater than 2.5 g/dL

Renal

  • Creatinine no greater than 1.5 times ULN

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Willing and able to attend follow-up visits
  • Concurrent enrollment on protocol ECOG-E1Y03 allowed
  • No active infection within the past 4 weeks
  • No other 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)
  • No history of active collagen vascular disease (i.e., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma)
  • No signs or symptoms of peptic or duodenal ulcer disease
  • No concurrent serious systemic disorders that are incompatible with study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for pancreatic cancer

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy
  • No concurrent intensity modulated radiotherapy

Surgery

  • See Disease Characteristics

Other

  • More than 4 weeks since prior investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00057876

  Hide Study Locations
Locations
United States, Arizona
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
United States, Arkansas
Saint Joseph's Mercy Cancer Center
Hot Springs, Arkansas, United States, 71913
United States, California
California Cancer Center - Woodward Park Office
Fresno, California, United States, 93720
Doctors Medical Center
Modesto, California, United States, 95350
Memorial Medical Center Cancer Services
Modesto, California, United States, 95355
United States, Colorado
McKee Medical Center
Loveland, Colorado, United States, 80539
North Colorado Medical Center
Greeley, Colorado, United States, 80631
United States, Connecticut
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
New Britain General Hospital
New Britain, Connecticut, United States, 06050
William W. Backus Hospital
Norwich, Connecticut, United States, 06360
Yale Comprehensive Cancer Center at Yale University School of Medicine
New Haven, Connecticut, United States, 06520-8032
United States, Florida
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
Halifax Medical Center
Daytona Beach, Florida, United States, 32115
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224-9980
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610
United States, Georgia
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States, 30033
Emory University Hospital - Atlanta
Altanta, Georgia, United States, 30322
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
Valdosta, Georgia, United States, 31603
Cancer Care and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Illinois
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Community Cancer Center
Normal, Illinois, United States, 61761
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Deerpath Medical Associates
Lake Forest, Illinois, United States, 60045
Provena St. Mary's Wasser Regional Cancer Center - Kankakee
Kankakee, Illinois, United States, 60901
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, United States, 60201
Galesburg Clinic
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Graham Hospital
Canton, Illinois, United States, 61520
Hematology and Oncology Associates
Chicago, Illinois, United States, 60611
Hematology Oncology Associates - Skokie
Skokie, Illinois, United States, 60076
Hematology/Oncology of the North Shore at Gross Point Medical Center
Skokie, Illinois, United States, 60076
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States, 60521
Hopedale Medical Complex
Hopedale, Illinois, United States, 61747
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
InterCommunity Cancer Center of Western Illinois
Galesburg, Illinois, United States, 61401
Joliet Oncology Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Kewanee Hospital
Kewanee, Illinois, United States, 61443
La Grange Memorial Hospital
La Grange, Illinois, United States, 60525
Mason District Hospital
Havana, Illinois, United States, 62644
McDonough District Hospital
Macomb, Illinois, United States, 61455
Memorial Hospital
Carthage, Illinois, United States, 62321
Mercy Hospital and Medical Center
Chicago, Illinois, United States, 60616
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Midwest Cancer Research Group, Incorporated
Skokie, Illinois, United States, 60077
Midwest Center for Hematology/Oncology
Joliet, Illinois, United States, 60432
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville, Illinois, United States, 60048
Northwest Medical Specialist, PC
Niles, Illinois, United States, 60714
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61615
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Proctor Hospital
Peoria, Illinois, United States, 61614
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
St. Anthony's Memorial Hospital
Effingham, Illinois, United States, 62401
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
Valley Cancer Center
Spring Valley, Illinois, United States, 61362
Swedish American Hospital
Rockford, Illinois, United States, 61104
Swedish Covenant Hospital
Chicago, Illinois, United States, 60625
St. Margaret's Hospital
Spring Valley, Illinois, United States, 61362
United States, Indiana
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46815
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
William N. Wishard Memorial Hospital
Indianapolis, Indiana, United States, 46202
United States, Iowa
Burgess Health Center
Onawa, Iowa, United States, 51040
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, United States, 52803
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Mercy Capitol Hospital
Des Moines, Iowa, United States, 50307
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines, Iowa, United States, 50266
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
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, 50314
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, United States, 50401
McFarland Clinic, P.C.
Ames, Iowa, United States, 50010
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
Ottumwa Regional Health Center Cancer Center
Ottumwa, Iowa, United States, 52501
Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
Sioux City, Iowa, United States, 51101
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
United States, Louisiana
Baton Rouge General Regional Cancer Center
Baton Rouge, Louisiana, United States, 70806
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States, 70809
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Medical Center of Louisiana - New Orleans
New Orleans, Louisiana, United States, 70112
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287-8936
United States, Massachusetts
Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Borgess Medical Center
Kalamazooaa, Michigan, United States, 49001
Green Bay Oncology, Limited - Iron Mountain
Iron Mountain, Michigan, United States, 49801
Haematology-Oncology Associates of Ohio and Michigan, P.C.
Lambertville, Michigan, United States, 48144
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
St. Joseph, Michigan, United States, 49085
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Mercy Memorial Hospital System
Monroe, Michigan, United States, 48162
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
CentraCare Clinic - River Campus
St. Cloud, Minnesota, United States, 56303
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, United States, 55422
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Miller-Dwan Medical Center
Duluth, Minnesota, United States, 55805
Park Nicollet Health Services
St. Louis Park, Minnesota, United States, 55416
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55403
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, United States, 55805
United Hospital
St. Paul, Minnesota, United States, 55102
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
United States, Missouri
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Great Falls Clinic
Great Falls, Montana, United States, 59405
United States, Nebraska
Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Bryan LGH Medical Center West
Lincoln, Nebraska, United States, 68502
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States, 68510
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Good Samaritan Health Systems
Kearney, Nebraska, United States, 68847
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska, United States, 68046
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha, Nebraska, United States, 68114
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Booker Cancer Center at Riverview Medical Center
Red Bank, New Jersey, United States, 07701
Community Regional Cancer Center at Community Medical Center
Toms River, New Jersey, United States, 08755
Fox Chase Virtua Health Cancer Program - Marlton
Marlton, New Jersey, United States, 08053
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07018-1095
Shore Memorial Hospital - Somers Point
Somers Point, New Jersey, United States, 08244
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington, New Jersey, United States, 08822
United States, New York
Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital
Cooperstown, New York, United States, 13326
United States, North Carolina
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
Greenville, North Carolina, United States, 27858
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Wilson Medical Center
Wilson, North Carolina, United States, 27893
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28401
United States, North Dakota
Trinity Cancer Care Center
Minot, North Dakota, United States, 58701
Cancer Care Center at Medcenter One Hospital
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic, P.C.
Bismarck, North Dakota, United States, 58501
St. Alexius Medical Center
Bismarck, North Dakota, United States, 58501
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
United States, Ohio
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, United States, 44710
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623
Firelands Regional Medical Center
Sandusky, Ohio, United States, 44870
St. Rita's Medical Center
Lima, Ohio, United States, 45801
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, United States, 44106
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Medical College of Ohio Cancer Institute
Toledo, Ohio, United States, 43614
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Promedica Cancer Center at Flower Hospital
Sylvania, Ohio, United States, 43560
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
St. Elizabeth Boardman Cancer Center
Boardman, Ohio, United States, 44512
St. Elizabeth Cancer Center at St. Elizabeth Health Center - Youngstown
Youngstown, Ohio, United States, 44510
St. Joseph Health Care Center
Warren, Ohio, United States, 44484
St. Luke's Hospital
Maumee, Ohio, United States, 43537
Fremont Memorial Hospital
Fremont, Ohio, United States, 43420
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
Toledo Hospital
Toledo, Ohio, United States, 43606
University Hospitals Ireland Cancer Center at Mercy Medical Center
Canton, Ohio, United States, 44708
United States, Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Guthrie Medical Center - Sayre
Sayre, Pennsylvania, United States, 18840
Hematology and Oncology Associates
Scranton, Pennsylvania, United States, 18510
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburg, Pennsylvania, United States, 15213
Jennersville Regional Hospital
West Grove, Pennsylvania, United States, 19390
Chester County Hospital
West Chester, Pennsylvania, United States, 19380
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Phoenixville Hospital
Phoenixville, Pennsylvania, United States, 19460
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301
Reading Hospital and Medical Center
West Reading, Pennsylvania, United States, 19612
St. Joseph Medical Center
Reading, Pennsylvania, United States, 19604
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh, Pennsylvania, United States, 15240
United States, South Dakota
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center, P. C.
Sioux Falls, South Dakota, United States, 57105
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee
Knoxville, Tennessee, United States, 37920
Thompson Cancer Survival Center
Knoxville, Tennessee, United States, 37916
United States, Texas
Doctor's Hospital of Laredo
Laredo, Texas, United States, 78041
East Texas Medical Center Cancer Institute
Tyler, Texas, United States, 75701
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410
United States, Utah
LDS Hospital
Salt Lake City, Utah, United States, 84143
Dixie Regional Medical Center
St. George, Utah, United States, 84770
Cottonwood Hospital Medical Center
Murray, Utah, United States, 84107
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States, 84106
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84603
United States, Virginia
Bon Secours Cancer Care at St. Mary's Hospital
Richmond, Virginia, United States, 23226
Martha Jefferson Hospital Cancer Care Center
Charlottesville, Virginia, United States, 22901
United States, Washington
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98114
United States, West Virginia
Marshall University Medical Center
Huntington, West Virginia, United States, 25701
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
Charleston, West Virginia, United States, 25304
United States, Wisconsin
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Cancer Care Center at Holy Family Memorial Medical Center
Manitowoc, Wisconsin, United States, 54221
Central Wisconsin Cancer Program at Agnesian HealthCare
Fond Du Lac, Wisconsin, United States, 54935
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
St. Mary's Hospital Medical Center
Green Bay, Wisconsin, United States, 54303
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54301
University of Wisconsin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, United States, 54401
South Africa
Pretoria Academic Hospital
Pretoria, 0001, South Africa
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Radiation Therapy Oncology Group
Investigators
Study Chair: Patrick J. Loehrer, MD Indiana University Melvin and Bren Simon Cancer Center
Study Chair: Christopher H. Crane, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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 ID Numbers: CDR0000278947, ECOG-E4201, RTOG-ECOG-E4201
Study First Received: April 7, 2003
Last Updated: May 29, 2009
ClinicalTrials.gov Identifier: NCT00057876     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III pancreatic cancer
adenocarcinoma of the pancreas

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Enzyme Inhibitors
 Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Radiation-Sensitizing Agents
Therapeutic Uses
Pancreatic Diseases
Gemcitabine
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 30, 2009



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