Phase III Randomized Trial of Taxotere/Cisplatin Followed by FOLFIRI or the Reverse Sequence in Unresectable Gastric Cancer
Gastric cancer is the second leading cause of cancer death worldwide and is the most common
malignancy in Korea. Metastatic gastric cancer remains a therapeutic challenge for medical
oncologists due to poor prognosis. A recent phase III trial comparing
docetaxel-cisplatin-5-FU (DCF) to the reference arm of cisplatin-5-FU (CF) showed a
significant superiority of DCF in terms of survival, time-to-progression, and response rate.
However, because DCF regimen was associated with high incidence of toxicities, the regimen
has not yet been widely accepted as the standard first-line chemotherapy for gastric cancer
patients. Thus, the optimum front-line chemotherapy regimen should be extensively
investigated in these patients to improve survival.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Second progress-free survival
Won Ki Kang, MD
Samsung Medical Center
Korea: Food and Drug Administration
SMC IRB 2005-03-044