Spots Global Cancer Trial Database for Triplet Combination of Cytotoxics as First-line Treatment for Metastatic Gastric Cancer

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Trial Identification

Brief Title: Triplet Combination of Cytotoxics as First-line Treatment for Metastatic Gastric Cancer

Official Title: Irinotecan Plus Oxaliplatin, 5-fluorouracil and Leucovorin as First-line Treatment for Metastatic Gastric Cancer

Study ID: NCT04358354

Conditions

Metastatic Gastric Cancer

Interventions

Irinotecan

Oxaliplatin

5-fluorouracil

Study Description

Brief Summary: This parallel, randomized, open-label study will evaluate the effect on overall survival of irinotecan on oxaliplatin and 5-fluorouracil (5-FU) in patients with HER2-negative and pMMR metastatic gastric cancer. Irinotecan will be administered as intravenous infusion of 150 mg/m2 every 2 weeks. Oxaliplatin will be given 85 mg/m2 and 5-FU will be given 400mg/m2 iv and 2400mg/m2 civ 48 hours fortnightly. Treatment will continue until disease progress or untolerable toxicity appears. The target sample size is 350-400 patients.

Detailed Description: Eligible patients will be randomly assigned to FOLFOXiri group and FOLFOX group. Stratification factors include ECOG PS, disease extent and pathological subtypes. Efficacy will be evaluated every 3-4 cycles with RECIST. Toxicity will be assessed with WHO CTC 3.0 every 2 weeks.