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Sponsored by: |
Medical Research Council |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002615 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not known whether receiving chemotherapy before surgery may be more effective than surgery alone in treating patients with stomach cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery plus combination chemotherapy with surgery alone in treating patients with stomach cancer.
Condition | Intervention | Phase |
---|---|---|
Gastric Cancer |
Drug: cisplatin Drug: epirubicin hydrochloride Drug: fluorouracil Procedure: conventional surgery |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A RANDOMISED, CONTROLLED TRIAL OF PRE- AND POST-OPERATIVE CHEMOTHERAPY IN PATIENTS WITH OPERABLE GASTRIC CANCER |
Estimated Enrollment: | 500 |
Study Start Date: | June 1994 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center and performance status (0 vs 1).
Quality of life is assessed at baseline, at completion of study therapy, and then every 6 months for 2 years.
Patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 4 years.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study ID Numbers: | CDR0000063914, MRC-ST02, EU-94035 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00002615 History of Changes |
Health Authority: | United States: Federal Government |
stage II gastric cancer stage III gastric cancer adenocarcinoma of the stomach |
Antimetabolites Digestive System Neoplasms Immunologic Factors Gastrointestinal Diseases Immunosuppressive Agents Epirubicin Anti-Bacterial Agents Digestive System Diseases |
Stomach Diseases Cisplatin Stomach Neoplasms Fluorouracil Gastrointestinal Neoplasms Stomach Cancer Adenocarcinoma |
Antimetabolites Antimetabolites, Antineoplastic Digestive System Neoplasms Immunologic Factors Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents |
Epirubicin Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Stomach Diseases Stomach Neoplasms Fluorouracil Therapeutic Uses Gastrointestinal Neoplasms |