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Spots Global Cancer Trial Database for Fluorouracil, Gemcitabine, and Radiation Therapy in Treating Patients With Cancer of the Pancreas

The following info and data is provided "as is" to help patients around the globe.
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Trial Identification

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

Official Title: A Phase III Study of Pre and Post Chemoradiation 5-FU vs. Pre and Post Chemoradiation Gemcitabine for Postoperative Adjuvant Treatment of Resected Pancreatic Adenocarcinoma

Study ID: NCT00003216

Study Description

Brief Summary: 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.

Detailed Description: 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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States

MBCCOP - Gulf Coast, Mobile, Alabama, United States

CCOP - Greater Phoenix, Phoenix, Arizona, United States

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

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

Arizona Cancer Center, Tucson, Arizona, United States

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

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

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

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

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

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States

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

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

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

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

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

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

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

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

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

MBCCOP - Howard University Cancer Center, Washington, District of Columbia, United States

Mayo Clinic, Jacksonville, Florida, United States

CCOP - Atlanta Regional, Atlanta, Georgia, United States

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

Cancer Research Center of Hawaii, Honolulu, Hawaii, United States

Tripler Army Medical Center, Honolulu, Hawaii, United States

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

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

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

CCOP - Central Illinois, Decatur, Illinois, United States

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

Loyola University Medical Center, Maywood, Illinois, United States

University of Kansas Medical Center, Kansas City, Kansas, United States

CCOP - Wichita, Wichita, Kansas, United States

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

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

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

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

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

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

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

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

Boston Medical Center, Boston, Massachusetts, United States

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

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

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

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

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

Henry Ford Hospital, Detroit, Michigan, United States

CCOP - Beaumont, Royal Oak, Michigan, United States

Providence Hospital - Southfield, Southfield, Michigan, United States

CCOP - Duluth, Duluth, Minnesota, United States

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

University of Mississippi Medical Center, Jackson, Mississippi, United States

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Barrett Cancer Center, Cincinnati, Ohio, United States

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States

CCOP - Columbus, Columbus, Ohio, United States

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

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

CCOP - Dayton, Kettering, Ohio, United States

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

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

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

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

Oregon Cancer Institute, Portland, Oregon, United States

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

Medical University of South Carolina, Charleston, South Carolina, United States

CCOP - Greenville, Greenville, South Carolina, United States

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

Brooke Army Medical Center, Fort Sam Houston, Texas, United States

University of Texas Medical Branch, Galveston, Texas, United States

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

Baylor College of Medicine, Houston, Texas, United States

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

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

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

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

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

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

Huntsman Cancer Institute, Salt Lake City, Utah, United States

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

Eastern Virginia Medical School, Norfolk, Virginia, United States

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

Swedish Cancer Institute, Seattle, Washington, United States

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

CCOP - Northwest, Tacoma, Washington, United States

Madigan Army Medical Center, Tacoma, Washington, United States

British Columbia Cancer Agency, Vancouver, British Columbia, Canada

Contact Details

Name: William F. Regine, MD

Affiliation: Lucille P. Markey Cancer Center at University of Kentucky

Role: STUDY_CHAIR

Name: Al B. Benson, MD, FACP

Affiliation: Robert H. Lurie Cancer Center

Role: STUDY_CHAIR

Name: John S. MacDonald, MD

Affiliation: Beth Israel Comprehensive Cancer Center - West Side Campus

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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