Combination Chemotherapy and Surgery in Treating Patients With Locally Advanced Stomach Cancer
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.
Drug: Immediate surgery
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase III Trial of Preoperative vs. Postoperative Chemotherapy With Taxotere-Cisplatin-5FU (TCF) in Patients With Locally Advanced Operable Gastric Carcinoma|
- Event-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Time to treatment failure measured after completion of study treatment [ Designated as safety issue: No ]
- Toxicity measured after completion of study treatment [ Designated as safety issue: Yes ]
- Rate of complete resection (RO) and postoperative mortality as measured after surgery [ Designated as safety issue: No ]
|Study Start Date:||November 1999|
|Study Completion Date:||March 2006|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
Active Comparator: Taxotere-Cisplatin-5FU preoperatively
Active Comparator: Immediate surgery followed by TCF
Surgery followed by Taxotere-Cisplatin-5FU
Drug: Immediate surgery
Immediate surgery followed by Taxotere-Cisplatin-5FU
- Compare, by intention to treat analysis, feasibility and efficacy of 4 courses of docetaxel, cisplatin, and fluorouracil as preoperative or postoperative chemotherapy in patients with locally advanced operable gastric carcinoma.
- Evaluate the predictive values of some biological and molecular tumor parameters on response to chemotherapy, metastasis and survival in this patient population.
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).
- Arm I: Patients receive docetaxel IV over 1 hour followed by cisplatin IV over 4 hours on day 1, and fluorouracil IV continuously on days 1-14 every 3 weeks. Patients are evaluated after 2 courses and patients with progressive disease proceed to immediate surgery. Otherwise, treatment continues for a total of 4 courses in the absence of unacceptable toxicity or disease progression. Between 3-5 weeks following day 1 of the last course of chemotherapy, patients undergo gastric resection.
- Arm II: Patients undergo immediate gastric resection. Beginning 3-6 weeks after surgery, patients receive 4 courses of docetaxel, cisplatin, and fluorouracil as in arm I.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005060
|European Institute of Oncology|
|Milan, Italy, 20141|
|Hopital Cantonal Universitaire de Geneve|
|Geneva, Switzerland, CH-1211|
|Zentrum fuer Tumordiagnostikund Praevention|
|St. Gallen, Switzerland, CH-9006|
|Study Chair:||Rudolf Morant, MD||Tumor Zentrum ZeTup St. Gallen und Chur|