Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer
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.
Drug: leucovorin calcium
Procedure: neoadjuvant therapy
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|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|
|Primary Completion Date:||February 2004 (Final data collection date for primary outcome measure)|
- Compare overall survival in patients with locally advanced gastric cancer treated with surgery alone or in combination with neoadjuvant cisplatin, leucovorin calcium and fluorouracil.
- Compare these two regimens in terms of the rate of complete resection, time to progression, and morbidity in these patients.
- Evaluate toxicity of and disease response to neoadjuvant chemotherapy in these patients.
- Evaluate quality of life and performance status in these patients pre- and post-surgery and compare quality of life for both regimens.
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.
- Arm I: Patients receive cisplatin IV over 1 hour on days 1, 15, and 29. Patients also receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours on days 1, 8, 15, 22, 29, and 36. A second course is administered beginning 2 weeks later in the absence of disease progression or unacceptable toxicity.
Patients undergo resection and lymphadenectomy on days 57-63 of the second course of chemotherapy.
- Arm II: Patients undergo resection and lymphadenectomy within 14 days of randomization.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004099
|Institut Jules Bordet|
|Brussels, Belgium, 1000|
|National Cancer Institute of Egypt|
|Robert Roessle Klinik|
|Berlin, Germany, D-13122|
|Medizinische Klinik I|
|Dresden, Germany, D-01307|
|Duesseldorf, Germany, D-40225|
|Department of Medicine III|
|Erlangen, Germany, D-91054|
|Kliniken Essen - Mitte|
|Essen, Germany, D-45136|
|Evangelisches Bethesda Krankenhaus GmbH|
|Essen, Germany, D-45355|
|Klinikum der J.W. Goethe Universitaet|
|Frankfurt, Germany, D-60590|
|Frankfurt, Germany, D-60488|
|Universitatsklinik - Saarland|
|Homburg, Germany, D-66421|
|Klinik & Poliklinik fur Strahlentherapie der Universitat zu Koln|
|Koln, Germany, D-50924|
|Meissen, Germany, D-01657|
|Muenster, Germany, DOH-48149|
|Klinikum Rechts Der Isar/Technische Universitaet Muenchen|
|Munich, Germany, D-81675|
|Solingen, Germany, D-42653|
|Academisch Ziekenhuis Maastricht|
|Maastricht, Netherlands, 6202 AZ|
|Instituto Portugues de Oncologia Centro do Porto, SA|
|Porto, Portugal, 4200|
|Study Chair:||Christoph Schuhmacher||Technische Universität München|