Conditions: Gastric Cancer
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 158
Healthy volunteers: no

Brief summary:
This study will assess the safety and efficacy of Xeloda, given in combination with standard chemotherapy regimens, for the first-line treatment of advanced and/or metastatic gastric cancer. All patients will receive Xeloda in combination with one of 4 standard chemotherapy regimens; the dose of Xeloda will be from 625mg/m2 - 1000mg/m2 bid orally, depending on the chemotherapy regimen used. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Detailed description:

Arms:
arm 1: Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks. arm 2: Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks. arm 3: Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks. arm 4: Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.

Interventions: intervention 1: Cisplatin intervention 2: Capecitabine intervention 3: Epirubicin intervention 4: Cisplatin intervention 5: Capecitabine intervention 6: Oxaliplatin intervention 7: Docetaxel intervention 8: Capecitabine
Intervention descriptions: intervention 1: 80 mg/m2/day, intravenous (IV), every 3 weeks intervention 2: 1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle intervention 3: 50 mg/m2/day, IV, every 3 weeks intervention 4: 60 mg/m2/day, IV, every 3 weeks intervention 5: 625 mg/m2, oral, twice daily per 3-week cycle intervention 6: 130 mg/m2/day, IV, every 3 weeks intervention 7: 60 mg/m2/day, IV, every 3 weeks intervention 8: 825 mg/m2, oral, twice daily for 2 weeks

Protocol document: