NCT02114359.

Trial name or title	Comparison of efficacy and tolerance between combination therapy and monotherapy as first line chemotherapy in elderly participants with advanced gastric cancer: a multicenter randomized phase 3 study
Methods	Multicentre RCT Phase 3 Allocation: Randomised Intervention Model: Parallel assignment Masking: Open‐label Primary Purpose: Treatment
Participants	N = 332, >70 years, Eastern Cooperative Oncology Group 0‐2, Measurable or evaluable disease, HER‐2 negative
Interventions	Experimental: Platinum/fluoropyrimidine combination chemotherapy · Drug: Capecitabine/cisplatin Capecitabine/cisplatin (XP) : cisplatin 50 mg/m² (80% dose of 60 mg/²m) iv over 15 min D1, capecitabine 1000 mg/m² (80% dose of 1250 mg/m²) orally twice a day D1‐14, repeated at 3 weeks · Drug: S‐1/cisplatin S‐1/cisplatin (SP) : cisplatin 50 mg/m² (80% dose of 60 mg/²m) iv ov 15min D1, S‐1 30 mg/m² (80% dose of 40 mg/m²) orally twice a day D1‐14, repeated at 3 weeks · Drug: Capecitabine/oxaliplatin Capecitabine+oxaliplatin (XELOX): oxaliplatin 100 mg/m² (80% dose of 130 mg/m²)iv ov 120 min D1, capecitabine 800 mg/m² (80% dose of 1000 mg/m²) orally twice a day D1‐14, repeated at 3 weeks · Drug: 5‐fluorouracil/oxaliplatin 5‐fluorouracil/oxaliplatin (FOLFOX): oxaliplatin 80 mg/m² (80% dose of 100 mg/m²) iv ov 120 min, leucovorin 80 mg/m² (80% dose of 100 mg/m²) iv ov 120min, 5‐fluorouracil 1900 mg/m² (80% dose of 2400 mg/m²) iv ov 46h D1, repeated at 2 weeks Active Comparator: Fluoropyrimidine mono chemotherapy · Drug: Capecitabine Capecitabine : 1250 mg/m² orally twice a day D1‐14 repeated at 3 weeks (if Ccr < 60 mL/min, 1000 mg/m² orally twice a day) · Drug: S‐1 S‐1 : 40 mg/m² orally twice a day D1‐14 repeated at 3 weeks (if Ccr < 60 mL/min, 30 mg/m² orally twice a day) · Drug: 5‐fluorouracil 5‐fluorouracil (FL) : leucovorin 100 mg/m² iv ov 2h, 5‐fluorouracil 2400 mg/m² iv ov 46 h D1, repeated at 2 weeks Arm A (XP): cisplatin 50 mg/m² d1, capecitabine 1000 mg/m2 orally twice a day d 1‐14, repeated at day 21 Arm B (SP): cisplatin 50mg/m2 d1, S‐1 30mg/m2 orally twice a day d 1‐14, repeated at d 21 Arm C (XELOX): oxaliplatin 100 mg/m2d1, capecitabine 800 mg/² orally twice a day d1 ‐14, repeated at day 21 Arm D (FOLFOX): oxaliplatin 80 mg/m², leucovorin 80 mg/m², 5‐fluorouracil 1900 mg/m² ci 46 h d 1, repeated at day 14
Outcomes	Comparison of overall survival [Time frame: up to 3 years] Comparison of progression‐free survival [Time frame: up to 2 years] Comparison of response rate [Time frame: up to 2 years] Comparison of adverse events [Time frame: up to 2 years] Comparison of quality of life [Time frame: up to 2 years]
Starting date	February 2014
Contact information	In Sil Choi, M.D., Ph.D.; 82‐10‐9137‐3883; hmoischoi@hanmail.net
Notes	Sponsor and Collaborators: Seoul National University Hospital, Ministry of Health & Welfare, Korea, Korean Cancer Study Group