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| ID | Type | Description | Link |
|---|---|---|---|
| SWS-SAKK-43/99 | Other Identifier | SAKK | |
| EU-99042 |
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with surgery may kill more tumor cells. It is not yet known if chemotherapy followed by surgery is more effective than surgery followed by chemotherapy for stomach cancer.
PURPOSE: This randomized phase III trial is studying surgery followed by combination chemotherapy to see how well it works compared to combination chemotherapy followed by surgery in treating patients with locally advanced stomach cancer.
OBJECTIVES:
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to study center, tumor site (affecting the Z-line (cardia carcinoma Siewart II and III) vs rest of the stomach), and nodal status (positive vs negative). Patients are randomized to either preoperative chemotherapy followed by surgery (arm I) or surgery followed by postoperative chemotherapy (arm II).
Quality of life is assessed before the first and third courses of chemotherapy, before and after surgery, and then at 1, 3, and 6 months.
Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 240 patients (120 per arm) will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Taxotere-Cisplatin-5FU preoperatively | Active Comparator | TCF preoperatively |
|
| Immediate surgery followed by TCF | Active Comparator | Surgery followed by Taxotere-Cisplatin-5FU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taxotere-Cisplatin-5FU | Drug | Preoperatively |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | ||
| Time to treatment failure measured after completion of study treatment | ||
| Toxicity measured after completion of study treatment |
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DISEASE CHARACTERISTICS:
Histologically confirmed locally advanced gastric carcinoma that is considered operable
Lymph nodes considered positive by sonography should be at least 2 of the following:
No distant metastases, including peritoneal carcinomatosis
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Rudolf Morant, MD | Tumor Zentrum ZeTup St. Gallen und Chur | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Institute of Oncology | Milan | 20141 | Italy | |||
| Hopital Cantonal Universitaire de Geneve |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Immediate surgery |
| Drug |
Immediate surgery followed by Taxotere-Cisplatin-5FU |
|
| Rate of complete resection (RO) and postoperative mortality as measured after surgery |
| Geneva |
| CH-1211 |
| Switzerland |
| Zentrum fuer Tumordiagnostikund Praevention | Sankt Gallen | CH-9006 | Switzerland |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |