A Phase II Trial of Neoadjuvant Cisplatin - Fluorouracil Chemotherapy, Surgery and Adjuvant Radiation Therapy and 5-FU/Leucovorin for Gastric Cancer
OBJECTIVES: I. Evaluate the tolerability and toxic effects of neoadjuvant cisplatin plus
paclitaxel and postoperative chemoradiation therapy with fluorouracil plus leucovorin
calcium in patients with high-risk gastric cancer. II. 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.
Interventional
Primary Purpose: Treatment
David I. Rosenthal, MD
Study Chair
Abramson Cancer Center of the University of Pennsylvania
United States: Federal Government
CDR0000066237
NCT00003298
February 1999
Name | Location |
---|---|
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
University of Rochester Cancer Center | Rochester, New York 14642 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Colorado Cancer Research Program, Inc. | Denver, Colorado 80209-5031 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
New England Medical Center Hospital | Boston, Massachusetts 02111 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
Morristown Memorial Hospital | Morristown, New Jersey 07962-1956 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
CCOP - Evanston | Evanston, Illinois 60201 |
Veterans Affairs Medical Center - Lakeside Chicago | Chicago, Illinois 60611 |
CCOP - Marshfield Medical Research and Education Foundation | Marshfield, Wisconsin 54449 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus | Nashville, Tennessee 37212 |
Somerset Medical Center | Somerville, New Jersey 08876 |
Raritan Bay Medical Center | Perth Amboy, New Jersey 08861 |