Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
European Organization for Research and Treatment of Cancer |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004099 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if surgery alone or surgery combined with chemotherapy is more effective in treating stomach cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have stage II, stage III, or stage IV stomach cancer.
Condition | Intervention | Phase |
---|---|---|
Gastric Cancer |
Drug: cisplatin Drug: fluorouracil Drug: leucovorin calcium Procedure: neoadjuvant therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | Randomized Phase III Study of Preoperative Chemotherapy Followed by Surgery Versus Surgery Alone in Locally Advanced Gastric Cancer (cT3 and cT4NxM0) |
Study Start Date: | July 1999 |
OBJECTIVES:
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to center, primary tumor category (cT3 or cT4), localization of tumor (upper third including cardia II or III vs middle and lower third), gender, and histological subtype (intestinal vs nonintestinal).
Patients are randomized to one of two treatment arms.
Quality of life is assessed before randomization, every 3 months for 1 year and at 2 years after randomization.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, then every 3 months thereafter until death.
PROJECTED ACCRUAL: A total of 360 patients (180 per arm) will be accrued for this study over 4 years.
Ages Eligible for Study: | 18 Years to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven stage II-IV adenocarcinoma of the stomach including cardia carcinoma types II and III
No evidence of peritoneal carcinomatosis
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Belgium | |
Institut Jules Bordet | |
Brussels, Belgium, 1000 | |
Egypt | |
National Cancer Institute of Egypt | |
Cairo, Egypt | |
Germany | |
Department of Medicine III | |
Erlangen, Germany, D-91054 | |
Evangelisches Bethesda Krankenhaus GmbH | |
Essen, Germany, D-45355 | |
Krankenhaus Nordwest | |
Frankfurt, Germany, D-60488 | |
Kliniken Essen - Mitte | |
Essen, Germany, D-45136 | |
Klinikum der J.W. Goethe Universitaet | |
Frankfurt, Germany, D-60590 | |
Klinikum Rechts Der Isar/Technische Universitaet Muenchen | |
Munich, Germany, D-81675 | |
Klinik & Poliklinik fur Strahlentherapie der Universitat zu Koln | |
Koln, Germany, D-50924 | |
Kreiskrankenhaus Meissen | |
Meissen, Germany, D-01657 | |
Medizinische Klinik I | |
Dresden, Germany, D-01307 | |
Robert Roessle Klinik | |
Berlin, Germany, D-13122 | |
Staedtisches Krankenhaus | |
Solingen, Germany, D-42653 | |
Universitaetsklinik Duesseldorf | |
Duesseldorf, Germany, D-40225 | |
Universitatsklinik - Saarland | |
Homburg, Germany, D-66421 | |
Westfaelische Wilhelms-Universitaet | |
Muenster, Germany, DOH-48149 | |
Netherlands | |
Academisch Ziekenhuis Maastricht | |
Maastricht, Netherlands, 6202 AZ | |
Portugal | |
Instituto Portugues de Oncologia Centro do Porto, SA | |
Porto, Portugal, 4200 |
Investigator: | Christoph Schuhmacher | Technische Universität München |
Study ID Numbers: | CDR0000067315, EORTC-40954 |
Study First Received: | December 10, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004099 History of Changes |
Health Authority: | United States: Federal Government |
stage II gastric cancer stage III gastric cancer stage IV gastric cancer |
intestinal adenocarcinoma of the stomach diffuse adenocarcinoma of the stomach mixed adenocarcinoma of the stomach |
Antimetabolites Vitamin B Complex Digestive System Neoplasms Immunologic Factors Gastrointestinal Diseases Leucovorin Trace Elements Immunosuppressive Agents Calcium, Dietary Digestive System Diseases |
Stomach Diseases Cisplatin Vitamins Stomach Neoplasms Fluorouracil Gastrointestinal Neoplasms Micronutrients Stomach Cancer Adenocarcinoma |
Antimetabolites Vitamin B Complex Digestive System Neoplasms Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Growth Substances Physiological Effects of Drugs Leucovorin Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Stomach Diseases Vitamins Therapeutic Uses Stomach Neoplasms Fluorouracil Gastrointestinal Neoplasms Micronutrients |