Taxotere-Cisplatin-5FU (TCF) Versus Taxotere-Cisplatin (TC) Versus Epirubicin-Cisplatin-5FU (ECF) as Systemic Treatment for Advanced Gastric Carcinoma: A Randomized Phase II Trial
- Compare the efficacy and tolerability of docetaxel, cisplatin, and fluorouracil (TCF)
versus docetaxel and cisplatin (TC) versus epirubicin, cisplatin, and fluorouracil
(ECF) in patients with advanced gastric carcinoma.
- Compare the time to treatment failure, time to progression, and survival in this
patient population treated with these regimens.
- Compare the quality of life during the treatment period and after failure in this
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center, performance status (0 vs 1), and liver involvement (yes vs no). Patients are
randomized to one of three treatment arms.
- Arm I: Patients receive epirubicin IV bolus and cisplatin IV over 4 hours on day 1 plus
fluorouracil IV continuously on days 1-21.
- Arm II: Patients receive docetaxel IV over 1 hour and cisplatin IV over 4 hours on day
- Arm III: Patients receive docetaxel and cisplatin as in arm II and fluorouracil as in
Treatment regimen is repeated every 3 weeks for up to 8 courses in the absence of disease
progression or unacceptable toxicity.
Quality of life is assessed before randomization; at day 1 of courses 2, 4, and 6; and one
month after treatment failure.
Patients with complete response or partial response are followed monthly for 3 months.
PROJECTED ACCRUAL: Approximately 111 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Arnaud Roth, MD
Hopital Cantonal Universitaire de Geneve