Spots Global Cancer Trial Database for Chemotherapy and Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Stomach Who Have Undergone Surgery
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Trial Identification
Brief Title: Chemotherapy and Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Stomach Who Have Undergone Surgery
Official Title: A Randomized Phase II Comparison Of Two Cisplatin-Paclitaxel Containing Chemoradiation Regimens In Resected Gastric Cancers
Study ID: NCT00011960
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy such as cisplatin and paclitaxel 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. Cisplatin and paclitaxel may make the tumor cells more sensitive to radiation therapy and may kill any tumor cells remaining after surgery. PURPOSE: Randomized phase II trial to study the effectiveness of cisplatin, paclitaxel, and radiation therapy with or without fluorouracil in treating patients who have stage IB, stage IIB, or stage IIIB stomach cancer that has been removed during surgery.
Detailed Description: OBJECTIVES: * Compare the 2-year disease-free survival in patients with resected stage IB-IIIB gastric cancer treated with cisplatin, paclitaxel, and radiotherapy with or without fluorouracil vs therapy in the adjuvant arm of the intergroup adjuvant protocol 0116 (RTOG 90-18). (Arm I closed to accrual as of 6/18/03.) * Compare the safety and success of these regimens vs therapy in the intergroup adjuvant study. * Compare the toxic effects of these regimens vs therapy in the adjuvant arm of the intergroup study. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor stage (T1-2 vs T3 vs T4) and by number of involved lymph nodes (none vs 1-3 vs 4 or more). Patients are randomized to one of two treatment arms. (Arm I closed to accrual as of 6/18/03.) * Arm I (closed to accrual as of 6/18/03): Patients receive fluorouracil IV continuously and cisplatin IV over 1 hour on days 1-5 and 29-33 and paclitaxel IV continuously on days 1 and 29. At 3-4 weeks after completion of chemotherapy, patients receive radiotherapy once daily and fluorouracil IV continuously on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive paclitaxel IV over 3 hours on days 1, 8, 15, 22, and 29. * Arm II: Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on days 1 and 29. At 3-4 weeks after completion of chemotherapy, patients receive radiotherapy once daily and paclitaxel IV continuously on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive cisplatin IV over 1 hour on days 1, 8, 15, 22, and 29. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 94 patients will be accrued for this study within 3 years.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
Mobile Infirmary Medical Center, Mobile, Alabama, United States
Providence Alaska Medical Center, Anchorage, Alaska, United States
Foundation for Cancer Research and Education, Phoenix, Arizona, United States
Providence Saint Joseph Medical Center - Burbank, Burbank, California, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Sutter Health Western Division Cancer Research Group, Greenbrae, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California, United States
CCOP - Bay Area Tumor Institute, Oakland, California, United States
University of California Davis Cancer Center, Sacramento, California, United States
CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, United States
Memorial Hospital Cancer Center, Colorado Springs, Colorado, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver, Colorado, United States
Yale Comprehensive Cancer Center, New Haven, Connecticut, United States
Baptist Hospital of Miami, Miami, Florida, United States
Alexian Brothers Cancer Care Center, Elk Grove Village, Illinois, United States
Wendt Regional Cancer Center of Finley Hospital, Dubuque, Iowa, United States
Cancer Center at Lexington Clinic, Lexington, Kentucky, United States
Cancer Research Center at Boston Medical Center, Boston, Massachusetts, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
CCOP - Kansas City, Kansas City, Missouri, United States
Siteman Cancer Center, Saint Louis, Missouri, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha, Omaha, Nebraska, United States
John F. Kennedy Medical Center, Edison, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital, Mount Holly, New Jersey, United States
Community Medical Center, Toms River, New Jersey, United States
New York Methodist Hospital, Brooklyn, New York, United States
Highland Hospital of Rochester, Rochester, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York, United States
Wayne Memorial Hospital, Inc., Goldsboro, North Carolina, United States
Rutherford Hospital, Rutherfordton, North Carolina, United States
Akron General Medical Center, Akron, Ohio, United States
Akron City Hospital - Summa Health System, Akron, Ohio, United States
Ireland Cancer Center, Cleveland, Ohio, United States
CCOP - Dayton, Dayton, Ohio, United States
Blanchard Valley Medical Associates, Findlay, Ohio, United States
Lima Memorial Hospital, Lima, Ohio, United States
St. Charles Hospital, Oregon, Ohio, United States
Cancer Care Center, Incorporated, Salem, Ohio, United States
Firelands Regional Medical Center, Sandusky, Ohio, United States
Flower Hospital - ProMedica Health System, Sylvania, Ohio, United States
Medical College of Ohio Cancer Institute, Toledo, Ohio, United States
CCOP - Toledo Community Hospital, Toledo, Ohio, United States
Fulton County Health Center, Wauseon, Ohio, United States
Natalie Warren Bryant Cancer Center, Tulsa, Oklahoma, United States
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital, Allentown, Pennsylvania, United States
Bryn Mawr Hospital, Bryn Mawr, Pennsylvania, United States
Mercy Fitzgerald Hospital, Darby, Pennsylvania, United States
Delaware County Memorial Hospital, Drexel Hill, Pennsylvania, United States
Pocono Cancer Center, East Stroudsburg, Pennsylvania, United States
Paoli Memorial Hospital, Paoli, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital, Wynnewood, Pennsylvania, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Cottonwood Hospital Medical Center, Murray, Utah, United States
McKay-Dee Hospital Center, Ogden, Utah, United States
Dixie Regional Medical Center, Saint George, Utah, United States
University of Utah Health Sciences Center, Salt Lake City, Utah, United States
LDS Hospital, Salt Lake City, Utah, United States
University of Washington Medical Center, Seattle, Washington, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin, United States
St. Vincent Hospital, Green Bay, Wisconsin, United States
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, United States
Columbia Hospital, Milwaukee, Wisconsin, United States
St. Luke's Medical Center, Milwaukee, Wisconsin, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Contact Details
Name: David Paul Kelsen, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: STUDY_CHAIR
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