NCT03567629

Evaluate the Efficacy of Irinotecan Versus Oxaliplatin in the First-line Treatment of Refractory Metastatic Colorectal Cancer

A Prospective, Open-lable, Multicenter, Randomized, Controlled Phase II Clinical Trial to Evaluate the Efficacy of Irinotecan Versus Oxaliplatin in the First-line Treatment of Refractory Metastatic Colorectal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open-lable, multicenter, randomized, controlled, phase II clinical study. The aim is to evaluate the efficacy of Irinotecan versus Oxaliplatin in the first-line treatment of refractory metastatic colorectal cancer.

Detailed description

This trial is conducted in patients with the refractory metastatic colorectal cancer. Eligible patients are randomized into two arms at 1:1 ratio to receive Irinotecan-based regimen or Oxaliplatin-based regimen until progress of the disease, unacceptable toxicity or withdrawal of consent by the patient. Study evaluation time is until death of patient or a deadline set by the researchers.

Conditions

• mCRC

Interventions

Type	Name	Description
DRUG	Irinotecan	Irinotecan 180 mg / m2, intravenous drip, D1, combined with fluorouracil / calcium folinate or Capecitabine or S1; combine or not combine with Bevacizumab or Cetuximab; every 14 days for a cycle.
DRUG	Oxaliplatin	Oxaliplatin 85mg/m2 (two-week regimen) or 130mg/m2 (three week regimen), intravenous drip, D1, combined with fluorouracil / calcium folinate or Capecitabine or S1; combine or not combine with Bevacizumab or Cetuximab; every 14 or 21 days for a cycle.

Timeline

• Start date: 2018-05-29
• Primary completion: 2021-12-30
• Completion: 2023-12-30
• First posted: 2018-06-26
• Last updated: 2018-06-26

Locations

1 site across 1 country: China