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Fluorouracil, Gemcitabine, and Radiation Therapy in Treating Patients With Cancer of the Pancreas Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Fluorouracil, Gemcitabine, and Radiation Therapy in Treating Patients With Cancer of the Pancreas conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Fluorouracil, Gemcitabine, and Radiation Therapy in Treating Patients With Cancer of the Pancreas Clinical research trials and Fluorouracil, Gemcitabine, and Radiation Therapy in Treating Patients With Cancer of the Pancreas health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Fluorouracil, Gemcitabine, and Radiation Therapy in Treating Patients With Cancer of the Pancreas. Fluorouracil, Gemcitabine, and Radiation Therapy in Treating Patients With Cancer of the Pancreas Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Fluorouracil, Gemcitabine, and Radiation Therapy in Treating Patients With Cancer of the Pancreas clinical trial. Subjects frequently get the best healthcare possible for their Fluorouracil, Gemcitabine, and Radiation Therapy in Treating Patients With Cancer of the Pancreas condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.

Home > "F" Clinical Trials Conditions > Fluorouracil, Gemcitabine, and Radiation Therapy in Treating Patients With Cancer of the Pancreas

Fluorouracil, Gemcitabine, and Radiation Therapy in Treating Patients With Cancer of the Pancreas



Fluorouracil, Gemcitabine, and Radiation Therapy in Treating Patients With Cancer of the Pancreas

For Condition: stage 1 pancreatic cancer,stage 4A pancreatic cancer,stage 3 pancreatic cancer,stage 2 pancreatic cancer,adenocarcinoma of the pancreas
Status: No longer recruiting
Sponsor(s): Radiation Therapy Oncology Group , National Cancer Institute (NCI),Eastern Cooperative Oncology Group,Southwest Oncology Group
Synopsis: 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 radiation therapy with chemotherapy may kill more tumor cells. It is not yet known which treatment regimen is most effective for pancreatic cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and gemcitabine plus radiation therapy in treating patients with cancer of the pancreas who have undergone surgery.
Details: OBJECTIVES: - Compare the overall and disease-free survival of patients with resected adenocarcinoma of the pancreas treated with adjuvant fluorouracil-based chemoradiotherapy preceded and followed by fluorouracil vs gemcitabine. - Compare the local-regional and distant disease control in patients treated with these regimens. - Compare the acute and late toxic effects of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to nodal involvement (yes vs no), tumor diameter (less than 3 cm vs 3 cm or greater), and surgical margins (negative vs positive vs unknown). Patients are randomized to one of two treatment arms. - Arm I: Beginning 3-8 weeks after definitive surgical resection, patients receive fluorouracil IV continuously for 3 weeks. Beginning 1-2 weeks later, patients receive fluorouracil IV continuously concurrently with radiotherapy 5 days a week for 5.5 weeks. Beginning 3-5 weeks after completion of chemoradiotherapy, patients receive fluorouracil IV continuously for 4 weeks every 6 weeks for 2 courses. - Arm II: Beginning 3-8 weeks after definitive surgical resection, patients receive gemcitabine IV once weekly for 3 weeks. Beginning 1-2 weeks later, patients receive chemoradiotherapy as in arm I. Beginning 3-5 weeks after completion of chemoradiotherapy, patients receive gemcitabine IV once weekly for 3 weeks every 4 weeks for 3 courses. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 518 patients will be accrued for this study within 8.6 years.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the pancreas - Stage T1-4, N0-1 (stage I-IVA) - No M1 or NX staging - Primary tumor of the pancreas (pancreatic head, neck, uncinate process, or body/tail) and maximum diameter/dimension and tumor status at surgical margin known - Prior potentially curative gross resection within 3-8 weeks before study - No non-adenocarcinomas, adenosquamous carcinomas, islet cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct carcinoma, or ampullary carcinoma - No recurrent disease - Post-resection CA-19-9 level required PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGOT no greater than 5 times ULN Renal: - Creatinine no greater than 1.5 times ULN Other: - No significant nausea or vomiting - No prior malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix - Able to maintain adequate nutrition (at least 1,500 calories/day) - Feeding tube allowed - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy Surgery: - See Disease Characteristics
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
WilliamRegine,  Study Chair,  University of Kentucky

Veterans Affairs Medical Center - Lexington
Lexington,  Kentucky,  40502-2236
United States
 

MBCCOP - Gulf Coast
Mobile,  Alabama,  36688
United States
 

CCOP - Beaumont
Royal Oak,  Michigan,  48073-6769
United States
 

Veterans Affairs Medical Center - Denver
Denver,  Colorado,  80220
United States
 

St. Vincents Comprehensive Cancer Center
New York City,  New York,  10011
United States
 

University of Mississippi Medical Center
Jackson,  Mississippi,  39216-4505
United States
 

Chao Family Comprehensive Cancer Center
Orange,  California,  92868
United States
 

University of Kansas Medical Center
Kansas City,  Kansas,  66160-7353
United States
 

Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock,  Arkansas,  72205
United States
 

MBCCOP - LSU Medical Center
New Orleans,  Louisiana,  70112
United States
 

Veterans Affairs Medical Center - Biloxi
Biloxi,  Mississippi,  39531-2410
United States
 

Loyola University Medical Center
Maywood,  Illinois,  60153-5500
United States
 

MBCCOP - University of Illinois at Chicago
Chicago,  Illinois,  60612-7323
United States
 

Henry Ford Hospital
Detroit,  Michigan,  48202
United States
 

Veterans Affairs Outpatient Clinic - Martinez
Martinez,  California,  94553
United States
 

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix,  Arizona,  85012
United States
 

Barbara Ann Karmanos Cancer Institute
Detroit,  Michigan,  48201-1379
United States
 

Veterans Affairs Medical Center - Portland
Portland,  Oregon,  97207
United States
 

University of Colorado Cancer Center
Denver,  Colorado,  80010
United States
 

Veterans Affairs Medical Center - Jackson
Jackson,  Mississippi,  39216
United States
 

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines,  Illinois,  60141
United States
 

City of Hope Comprehensive Cancer Center
Duarte,  California,  91010
United States
 

CCOP - Columbia River Program
Portland,  Oregon,  97225
United States
 

University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham,  Alabama,  35294-3300
United States
 

CCOP - Wichita
Wichita,  Kansas,  67214-3882
United States
 

University of Texas Health Science Center at San Antonio
San Antonio,  Texas,  78284-7845
United States
 

Tripler Army Medical Center
Honolulu,  Hawaii,  96859-5000
United States
 

University of Texas Medical Branch
Galveston,  Texas,  77555-0565
United States
 

CCOP - Scott and White Hospital
Temple,  Texas,  76508
United States
 

Veterans Affairs Medical Center - West Los Angeles
Los Angeles,  California,  90073
United States
 

MBCCOP - University of New Mexico HSC
Albuquerque,  New Mexico,  87131
United States
 

CCOP - Dayton
Kettering,  Ohio,  45429
United States
 

University of California Davis Medical Center
Sacramento,  California,  95817
United States
 

Huntsman Cancer Institute
Salt Lake City,  Utah,  84112-5550
United States
 

Mayo Clinic
Jacksonville,  Florida,  32224
United States
 

Veterans Affairs Medical Center - Tucson
Tucson,  Arizona,  85723
United States
 

Baylor College of Medicine
Houston,  Texas,  77030
United States
 

USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles,  California,  90033-0804
United States
 

Veterans Affairs Medical Center - Charleston
Charleston,  South Carolina,  29401-5799
United States
 

Veterans Affairs Medical Center - Seattle
Seattle,  Washington,  98108
United States
 

Dwight David Eisenhower Army Medical Center
Fort Gordon,  Georgia,  30905-5650
United States
 

Veterans Affairs Medical Center - Salt Lake City
Salt Lake City,  Utah,  84148
United States
 

Western New York Urology Associates
Buffalo,  New York,  14220
United States
 

Cleveland Clinic Taussig Cancer Center
Cleveland,  Ohio,  44195-9001
United States
 

Veterans Affairs Medical Center - Shreveport
Shreveport,  Louisiana,  71130
United States
 

CCOP - Bay Area Tumor Institute
Oakland,  California,  94609-3305
United States
 

Medical University of South Carolina
Charleston,  South Carolina,  29425-0721
United States
 

University of Arkansas for Medical Sciences
Little Rock,  Arkansas,  72205
United States
 

Veterans Affairs Medical Center - Kansas City
Kansas City,  Missouri,  64128
United States
 

Arizona Cancer Center
Tucson,  Arizona,  85724
United States
 

Veterans Affairs Medical Center - San Francisco
San Francisco,  California,  94121
United States
 

Veterans Affairs Medical Center - Detroit
Detroit,  Michigan,  48201-1932
United States
 

Arthur G. James Cancer Hospital - Ohio State University
Columbus,  Ohio,  43210-1240
United States
 

Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio,  Texas,  78284
United States
 

CCOP - Northwest
Tacoma,  Washington,  98405-0986
United States
 

Cancer Research Center of Hawaii
Honolulu,  Hawaii,  96813-2424
United States
 

Veterans Affairs Medical Center - Albuquerque
Albuquerque,  New Mexico,  87108-5138
United States
 

CCOP - Santa Rosa Memorial Hospital
Santa Rosa,  California,  95403
United States
 

CCOP - Southeast Cancer Control Consortium
Winston Salem,  North Carolina,  27104-4241
United States
 

Texas Tech University Health Science Center
Lubbock,  Texas,  79415
United States
 

Eastern Virginia Medical School
Norfolk,  Virginia,  23510-1115
United States
 

Barrett Cancer Center
Cincinnati,  Ohio,  45267-0501
United States
 

University of Texas - MD Anderson Cancer Center
Houston,  Texas,  77030-4095
United States
 

CCOP - Duluth
Duluth,  Minnesota,  55805
United States
 

Louisiana State University Health Sciences Center - Shreveport
Shreveport,  Louisiana,  71130-3932
United States
 

Veterans Affairs Medical Center - Dayton
Dayton,  Ohio,  45428
United States
 

Oklahoma Medical Research Foundation
Oklahoma City,  Oklahoma,  73104
United States
 

Veterans Affairs Medical Center - Wichita
Wichita,  Kansas,  67218
United States
 

University of Michigan Comprehensive Cancer Center
Ann Arbor,  Michigan,  48109-0912
United States
 

CCOP - Greenville
Greenville,  South Carolina,  29615
United States
 

Madigan Army Medical Center
Tacoma,  Washington,  98431-5000
United States
 

Veterans Affairs Medical Center - Temple
Temple,  Texas,  76504
United States
 

Swedish Cancer Institute
Seattle,  Washington,  98104
United States
 

David Grant Medical Center
Travis Air Force Base,  California,  94535
United States
 

Oregon Cancer Institute
Portland,  Oregon,  97239
United States
 

Brooke Army Medical Center
Fort Sam Houston,  Texas,  78234-6200
United States
 

Boston Medical Center
Boston,  Massachusetts,  02118
United States
 

Providence Hospital - Southfield
Southfield,  Michigan,  48075-9975
United States
 

CCOP - Virginia Mason Research Center
Seattle,  Washington,  98101
United States
 

Veterans Affairs Medical Center - Houston
Houston,  Texas,  77030
United States
 

Veterans Affairs Medical Center - Ann Arbor
Ann Arbor,  Michigan,  48105
United States
 

Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago,  Illinois,  60611-3013
United States
 

Herbert Irving Comprehensive Cancer Center
New York City,  New York,  10032
United States
 

British Columbia Cancer Agency
Vancouver,  British Columbia,  V5Z 4E6
Canada
 

CCOP - Greater Phoenix
Phoenix,  Arizona,  85006-2726
United States
 

CCOP - Atlanta Regional
Atlanta,  Georgia,  30342-1701
United States
 

University of Rochester Medical Center
Rochester,  New York,  14642
United States
 

Veterans Affairs Medical Center - Oklahoma City
Oklahoma City,  Oklahoma,  73104
United States
 

CCOP - Columbus
Columbus,  Ohio,  43206
United States
 

Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain,  Massachusetts,  02130
United States
 

CCOP - St. Louis-Cape Girardeau
St. Louis,  Missouri,  63141
United States
 

Keesler Medical Center - Keesler AFB
Keesler AFB,  Mississippi,  39534-2576
United States
 

Veterans Affairs Medical Center - Albany
Albany,  New York,  12208
United States
 

CCOP - Cancer Research for the Ozarks
Springfield,  Missouri,  65807
United States
 

CCOP - Upstate Carolina
Spartanburg,  South Carolina,  29303
United States
 

CCOP - Central Illinois
Decatur,  Illinois,  62526
United States
 

CCOP - Montana Cancer Consortium
Billings,  Montana,  59101
United States
 

Jonsson Comprehensive Cancer Center, UCLA
Los Angeles,  California,  90095-1781
United States
 

St. Louis University Health Sciences Center
St. Louis,  Missouri,  63110
United States
 

CCOP - Kansas City
Kansas City,  Missouri,  64131
United States
 

Veterans Affairs Medical Center - Cincinnati
Cincinnati,  Ohio,  45220-2288
United States
 

MBCCOP - Howard University Cancer Center
Washington D.C.,  District of Columbia,  20060
United States
 

Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago,  Illinois,  60612
United States
 

Albert B. Chandler Medical Center, University of Kentucky
Lexington,  Kentucky,  40536-0084
United States
 

Tulane University School of Medicine
New Orleans,  Louisiana,  70112
United States
 

CCOP - Ann Arbor Regional
Ann Arbor,  Michigan,  48106
United States
 

Veterans Affairs Medical Center - New Orleans
New Orleans,  Louisiana,  70112
United States
 


Additional Information:
Study ID Numbers:
  CDR0000066076;  RTOG-9704,E-R9704,SWOG-R9704
Study Start Date: 
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003216

Other Stage 2 Pancreatic Cancer Studies:
1. Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer

2. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Pancreatic Cancer

3. Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas

4. DHA-Paclitaxel With or Without Gemcitabine in Treating Patients With Advanced Solid Tumors or Unresectable Pancreatic Cancer

5. Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

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