Spots Global Cancer Trial Database for Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer
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Trial Identification
Brief Title: Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer
Official Title: A Phase II Trial of Neoadjuvant Paclitaxel - Cisplatin Chemotherapy, Surgery and Adjuvant Radiation Therapy and 5-FU/Leucovorin for Gastric Cancer
Study ID: NCT00003298
Conditions
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 chemotherapy, radiation therapy, and surgery may kill more tumor cells. E7296 was conducted to study neoadjuvant chemotherapy and postoperative chemoradiation therapy in patients diagnosed with high-risk gastric cancer using a new neoadjuvant regimen: paclitaxel plus cisplatin. It was hypothesized that this new neoadjuvant chemotherapy followed by surgery and chemoradiation therapy would be well tolerated and would have a high curative resection rate.
Detailed Description: OBJECTIVES: Primary objective: To evaluate the tolerability and toxicity of neoadjuvant cisplatin plus paclitaxel and postoperative chemoradiation therapy with fluorouracil plus leucovorin calcium in patients with high-risk gastric cancer. Secondary objectives: To assess the pathologic response of gastric tumors to neoadjuvant cisplatin plus paclitaxel chemotherapy, and preliminarily assess the patterns of failure and disease free and overall survival. OUTLINE: Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days. Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment. Patients are followed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter. PROJECTED ACCRUAL: Approximately 30-42 patients will be accrued over 18 months.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CCOP - Colorado Cancer Research Program, Inc., Denver, Colorado, United States
Emory University Hospital - Atlanta, Atlanta, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States
Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois, United States
CCOP - Evanston, Evanston, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis, Indiana, United States
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States
CCOP - Ochsner, New Orleans, Louisiana, United States
New England Medical Center Hospital, Boston, Massachusetts, United States
CCOP - Ann Arbor Regional, Ann Arbor, Michigan, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Morristown Memorial Hospital, Morristown, New Jersey, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Raritan Bay Medical Center, Perth Amboy, New Jersey, United States
Somerset Medical Center, Somerville, New Jersey, United States
Albert Einstein Comprehensive Cancer Center, Bronx, New York, United States
University of Rochester Cancer Center, Rochester, New York, United States
Ireland Cancer Center, Cleveland, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
CCOP - MainLine Health, Wynnewood, Pennsylvania, United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus, Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
CCOP - Marshfield Medical Research and Education Foundation, Marshfield, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee, Wisconsin, United States
Contact Details
Name: David I. Rosenthal, MD
Affiliation: Abramson Cancer Center at Penn Medicine
Role: STUDY_CHAIR
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