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

Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Study ID
NCT04358354
Phase
PHASE3
Status
Unknown

Conditions

  • Metastatic Gastric Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    Irinotecan 150 mg/m2
  • Oxaliplatin — DRUG
    Oxaliplatin 85 mg/m2
  • 5-fluorouracil — DRUG
    5-fluorouracil 400 mg/m2 iv bolus and 2400 mg/m2 civ 46 hours

Study Details

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.

Key Dates

Start date
Oct 22, 2020
Status verified
Jul 2021
Primary completion
Dec 31, 2023
Completion
Dec 31, 2024

Study Design

Enrollment
388 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: FOLFOXiri group
    Irinotecan 150 mg/m2 iv drip d1; Oxaliplatin 85 mg/m2 iv drip d1; LV 200 mg/m2 iv drip d1; 5FU 400mg/m2 iv bolus and 2400 mg/m2 civ; The regimen will be repeated every 2 weeks until disease progression or untolerable toxicity.
  • Active Comparator: FOLFOX group
    Oxaliplatin: 85 mg/m2 iv drip d1; LV 200 mg/m2 iv drip d1; 5FU 400mg/m2 iv bolus and 2400 mg/m2 civ 46h; The regimen will be repeated every 2 weeks until disease progression or untolerable toxicity.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: 2 years ]

Central Contacts

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