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

Metastatic Gastric Cancer Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Metastatic Gastric Cancer
• Stomach Neoplasms

• NCT number: NCT04358354
• Study type: Interventional
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Xiaohui Zhai, MD, PhD
• Phone: 86-20-38285497
• Email: zhaixh@mail.sysu.edu.cn
• Status: Recruiting
• Phase: Phase 3
• Start date: October 22, 2020
• Completion date: December 31, 2024