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
3 other identifiers
interventional
74
2 countries
229
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 pancreatic-cancer
Started Aug 2003
Typical duration for phase_3 pancreatic-cancer
229 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2003
CompletedFirst Posted
Study publicly available on registry
April 9, 2003
CompletedStudy Start
First participant enrolled
August 29, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
March 25, 2011
CompletedJuly 5, 2023
June 1, 2023
5.7 years
April 7, 2003
February 28, 2011
June 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Progression-free Survival Time
assessed every 3 months for 2 years, then every 6 months for year 3
Overall Response
assessed at week 8, and every 3 months for 2 years, then every 6 months for year 3
Study Arms (2)
Gemcitabine
ACTIVE COMPARATORGemcitabine + Radiation
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- +4 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eastern Cooperative Oncology Grouplead
- National Cancer Institute (NCI)collaborator
- Radiation Therapy Oncology Groupcollaborator
Study Sites (229)
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006, United States
Saint Joseph's Mercy Cancer Center
Hot Springs, Arkansas, 71913, United States
California Cancer Center - Woodward Park Office
Fresno, California, 93720, United States
Doctors Medical Center
Modesto, California, 95350, United States
Memorial Medical Center Cancer Services
Modesto, California, 95355, United States
North Colorado Medical Center
Greeley, Colorado, 80631, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
New Britain General Hospital
New Britain, Connecticut, 06050, United States
Yale Comprehensive Cancer Center at Yale University School of Medicine
New Haven, Connecticut, 06520-8032, United States
William W. Backus Hospital
Norwich, Connecticut, 06360, United States
Halifax Medical Center
Daytona Beach, Florida, 32115, United States
University of Florida Shands Cancer Center
Gainesville, Florida, 32610, United States
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, 32207, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224-9980, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Cancer Care and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, 31405, United States
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
Valdosta, Georgia, 31603, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, 60507, United States
St. Joseph Medical Center
Bloomington, Illinois, 61701, United States
Graham Hospital
Canton, Illinois, 61520, United States
Memorial Hospital
Carthage, Illinois, 62321, United States
Hematology and Oncology Associates
Chicago, Illinois, 60611, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611, United States
Mercy Hospital and Medical Center
Chicago, Illinois, 60616, United States
Swedish Covenant Hospital
Chicago, Illinois, 60625, United States
St. Anthony's Memorial Hospital
Effingham, Illinois, 62401, United States
Eureka Community Hospital
Eureka, Illinois, 61530, United States
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, 60201, United States
Galesburg Clinic
Galesburg, Illinois, 61401, United States
Galesburg Cottage Hospital
Galesburg, Illinois, 61401, United States
InterCommunity Cancer Center of Western Illinois
Galesburg, Illinois, 61401, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, 60521, United States
Hopedale Medical Complex
Hopedale, Illinois, 61747, United States
Midwest Center for Hematology/Oncology
Joliet, Illinois, 60432, United States
Joliet Oncology Hematology Associates, Limited - West
Joliet, Illinois, 60435, United States
Provena St. Mary's Wasser Regional Cancer Center - Kankakee
Kankakee, Illinois, 60901, United States
Kewanee Hospital
Kewanee, Illinois, 61443, United States
La Grange Memorial Hospital
La Grange, Illinois, 60525, United States
Deerpath Medical Associates
Lake Forest, Illinois, 60045, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville, Illinois, 60048, United States
McDonough District Hospital
Macomb, Illinois, 61455, United States
Northwest Medical Specialist, PC
Niles, Illinois, 60714, United States
BroMenn Regional Medical Center
Normal, Illinois, 61761, United States
Community Cancer Center
Normal, Illinois, 61761, United States
Community Hospital of Ottawa
Ottawa, Illinois, 61350, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, 61554, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61603, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61615, United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61615, United States
OSF St. Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois Valley Community Hospital
Peru, Illinois, 61354, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
Swedish American Hospital
Rockford, Illinois, 61104, United States
Hematology Oncology Associates - Skokie
Skokie, Illinois, 60076, United States
Hematology/Oncology of the North Shore at Gross Point Medical Center
Skokie, Illinois, 60076, United States
Midwest Cancer Research Group, Incorporated
Skokie, Illinois, 60077, United States
St. Margaret's Hospital
Spring Valley, Illinois, 61362, United States
Valley Cancer Center
Spring Valley, Illinois, 61362, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46815, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
William N. Wishard Memorial Hospital
Indianapolis, Indiana, 46202, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, 46350, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, 46360, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Saint Joseph Regional Medical Center
South Bend, Indiana, 46617, United States
McFarland Clinic, P.C.
Ames, Iowa, 50010, United States
Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, 52803, United States
Mercy Capitol Hospital
Des Moines, Iowa, 50307, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, 50401, United States
Burgess Health Center
Onawa, Iowa, 51040, United States
Ottumwa Regional Health Center Cancer Center
Ottumwa, Iowa, 52501, United States
Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
Sioux City, Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines, Iowa, 50266, United States
Central Baptist Hospital
Lexington, Kentucky, 40503, United States
Baton Rouge General Regional Cancer Center
Baton Rouge, Louisiana, 70806, United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, 70809, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112, United States
Medical Center of Louisiana - New Orleans
New Orleans, Louisiana, 70112, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287-8936, United States
Tufts - New England Medical Center
Boston, Massachusetts, 02111, United States
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, 49221, United States
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, 49431, United States
Green Bay Oncology, Limited - Iron Mountain
Iron Mountain, Michigan, 49801, United States
Borgess Medical Center
Kalamazoo, Michigan, 49001, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Haematology-Oncology Associates of Ohio and Michigan, P.C.
Lambertville, Michigan, 48144, United States
Mercy Memorial Hospital System
Monroe, Michigan, 48162, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, 48073, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph, Michigan, 49085, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
CCOP - Duluth
Duluth, Minnesota, 55805, United States
Miller-Dwan Medical Center
Duluth, Minnesota, 55805, United States
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, 55432, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55403, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, 55422, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, 56303, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Health Services
Saint Louis Park, Minnesota, 55416, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203, United States
St. John's Regional Health Center
Springfield, Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Good Samaritan Health Systems
Kearney, Nebraska, 68847, United States
Bryan LGH Medical Center West
Lincoln, Nebraska, 68502, United States
Cancer Resource Center - Lincoln
Lincoln, Nebraska, 68510, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106, United States
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha, Nebraska, 68114, United States
Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
Creighton University Medical Center
Omaha, Nebraska, 68131, United States
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska, 68046, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018-1095, United States
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington, New Jersey, 08822, United States
Fox Chase Virtua Health Cancer Program - Marlton
Marlton, New Jersey, 08053, United States
Booker Cancer Center at Riverview Medical Center
Red Bank, New Jersey, 07701, United States
Shore Memorial Hospital - Somers Point
Somers Point, New Jersey, 08244, United States
Community Regional Cancer Center at Community Medical Center
Toms River, New Jersey, 08755, United States
Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital
Cooperstown, New York, 13326, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534, United States
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
Greenville, North Carolina, 27858, United States
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington, North Carolina, 28401, United States
Wilson Medical Center
Wilson, North Carolina, 27893, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Bismarck Cancer Center
Bismarck, North Dakota, 58501, United States
Cancer Care Center at Medcenter One Hospital
Bismarck, North Dakota, 58501, United States
Mid Dakota Clinic, P.C.
Bismarck, North Dakota, 58501, United States
St. Alexius Medical Center
Bismarck, North Dakota, 58501, United States
Trinity Cancer Care Center
Minot, North Dakota, 58701, United States
St. Elizabeth Boardman Cancer Center
Boardman, Ohio, 44512, United States
University Hospitals Ireland Cancer Center at Mercy Medical Center
Canton, Ohio, 44708, United States
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, 44710, United States
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, 44106, United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Blanchard Valley Medical Associates
Findlay, Ohio, 45840, United States
Fremont Memorial Hospital
Fremont, Ohio, 43420, United States
St. Rita's Medical Center
Lima, Ohio, 45801, United States
Lima Memorial Hospital
Lima, Ohio, 45804, United States
St. Luke's Hospital
Maumee, Ohio, 43537, United States
St. Charles Mercy Hospital
Oregon, Ohio, 43616, United States
Firelands Regional Medical Center
Sandusky, Ohio, 44870, United States
Promedica Cancer Center at Flower Hospital
Sylvania, Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883, United States
Toledo Hospital
Toledo, Ohio, 43606, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
Medical College of Ohio Cancer Institute
Toledo, Ohio, 43614, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43623, United States
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, 43623, United States
St. Joseph Health Care Center
Warren, Ohio, 44484, United States
Fulton County Health Center
Wauseon, Ohio, 43567, United States
St. Elizabeth Cancer Center at St. Elizabeth Health Center - Youngstown
Youngstown, Ohio, 44510, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, 74136, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17604, United States
Lewistown Hospital
Lewistown, Pennsylvania, 17044, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141, United States
Phoenixville Hospital
Phoenixville, Pennsylvania, 19460, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213, United States
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh, Pennsylvania, 15240, United States
St. Joseph Medical Center
Reading, Pennsylvania, 19604, United States
Guthrie Medical Center - Sayre
Sayre, Pennsylvania, 18840, United States
Hematology and Oncology Associates
Scranton, Pennsylvania, 18510, United States
Mount Nittany Medical Center
State College, Pennsylvania, 16803, United States
Chester County Hospital
West Chester, Pennsylvania, 19380, United States
Jennersville Regional Hospital
West Grove, Pennsylvania, 19390, United States
Reading Hospital and Medical Center
West Reading, Pennsylvania, 19612, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, 19096, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, 57104, United States
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, 57105, United States
Medical X-Ray Center, P. C.
Sioux Falls, South Dakota, 57105, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916, United States
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee
Knoxville, Tennessee, 37920, United States
Doctor's Hospital of Laredo
Laredo, Texas, 78041, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410, United States
East Texas Medical Center Cancer Institute
Tyler, Texas, 75701, United States
Cottonwood Hospital Medical Center
Murray, Utah, 84107, United States
McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, 84603, United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, 84106, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Dixie Regional Medical Center
St. George, Utah, 84770, United States
Martha Jefferson Hospital Cancer Care Center
Charlottesville, Virginia, 22901, United States
Bon Secours Cancer Care at St. Mary's Hospital
Richmond, Virginia, 23226, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, 98114, United States
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
Charleston, West Virginia, 25304, United States
Marshall University Medical Center
Huntington, West Virginia, 25701, United States
Central Wisconsin Cancer Program at Agnesian HealthCare
Fond du Lac, Wisconsin, 54935, United States
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin, 54301-3526, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54301, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, 54303, United States
St. Mary's Hospital Medical Center
Green Bay, Wisconsin, 54303, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Cancer Care Center at Holy Family Memorial Medical Center
Manitowoc, Wisconsin, 54221, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, 54449, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235, United States
University of Wisconsin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, 54401, United States
Pretoria Academic Hospital
Pretoria, South Africa
Related Publications (1)
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.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- Eastern Cooperative Oncology Group (ECOG) Statistical Office
Study Officials
- STUDY CHAIR
Patrick J. Loehrer, MD
Indiana University Melvin and Bren Simon Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2003
First Posted
April 9, 2003
Study Start
August 29, 2003
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
July 5, 2023
Results First Posted
March 25, 2011
Record last verified: 2023-06