NCT04358354

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 388 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Gastric Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan	Irinotecan 150 mg/m2
DRUG	Oxaliplatin	Oxaliplatin 85 mg/m2
DRUG	5-fluorouracil	5-fluorouracil 400 mg/m2 iv bolus and 2400 mg/m2 civ 46 hours

Timeline

• Start date: 2020-10-22
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2020-04-24
• Last updated: 2021-07-19

Locations

1 site across 1 country: China