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Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsor: Eastern Cooperative Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003298
  Purpose

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.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy, surgery, and radiation therapy in treating patients with gastric cancer.


Condition Intervention Phase
Gastric Cancer
Drug: cisplatin
Drug: fluorouracil
Drug: leucovorin calcium
Drug: paclitaxel
Procedure: surgical procedure
Radiation: radiation therapy
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Trial of Neoadjuvant Cisplatin - Fluorouracil Chemotherapy, Surgery and Adjuvant Radiation Therapy and 5-FU/Leucovorin for Gastric Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 42
Study Start Date: February 1999
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction Localized cancer that is potentially curable by surgery (T2, N1-2, M0 or T3-4, any N, M0) No metastatic cancer to the ovaries

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: WBC at least 4,000 cells/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin less than 2 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance greater than 50 mL/min Other: No clinically significant auditory impairment Caloric intake must be at least 1500 kcal/day No prior history of cancer within the past 5 years except for basal cell carcinoma of the skin or in situ carcinoma of the cervix Not pregnant or lactating Fertile patients must use adequate contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy, except for skin cancer Surgery: See Disease Characteristics

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003298

  Hide Study Locations
Locations
United States, Colorado
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, United States, 80209-5031
United States, Georgia
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
United States, Illinois
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Evanston
Evanston, Illinois, United States, 60201
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States, 46202
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
New England Medical Center Hospital
Boston, Massachusetts, United States, 02111
United States, Michigan
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States, 48106
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68131
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962-1956
Raritan Bay Medical Center
Perth Amboy, New Jersey, United States, 08861
Somerset Medical Center
Somerville, New Jersey, United States, 08876
United States, New York
Albert Einstein Comprehensive Cancer Center
Bronx, New York, United States, 10461
University of Rochester Cancer Center
Rochester, New York, United States, 14642
United States, Ohio
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States, 43623-3456
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
United States, Pennsylvania
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, United States, 37212
United States, Wisconsin
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States, 53295
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: David I. Rosenthal, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000066237, E-7296
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00003298     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II gastric cancer
stage III gastric cancer
stage IV gastric cancer
adenocarcinoma of the stomach

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Gastrointestinal Diseases
Physiological Effects of Drugs
Leucovorin
Stomach Diseases
Neoplasms by Site
Cisplatin
Stomach Neoplasms
Therapeutic Uses
Vitamins
Micronutrients
Digestive System Neoplasms
Vitamin B Complex
Growth Substances
Mitosis Modulators
Antimitotic Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Paclitaxel
Fluorouracil
Tubulin Modulators
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 30, 2009