A Phase III Trial of Preoperative vs. Postoperative Chemotherapy With Taxotere-Cisplatin-5FU (TCF) in Patients With Locally Advanced Operable Gastric Carcinoma
- 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
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
PROJECTED ACCRUAL: Approximately 240 patients (120 per arm) will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Rudolf Morant, MD
Tumor Zentrum ZeTup St. Gallen und Chur