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

Sponsor
Peking University
Study ID
NCT03567629
Phase
PHASE2
Status
Unknown

Conditions

  • mCRC

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    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.
  • Oxaliplatin — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 29, 2018
Status verified
Jun 2018
Primary completion
Dec 30, 2021
Completion
Dec 30, 2023

Study Design

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

Arms

  • Experimental: Irinotecan-based chemotherapy
  • Active Comparator: Oxaliplatin-based chemotherapy

Primary Outcome Measure

Progression-free Survival: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first. [ Time Frame: assessed up to 10 months ]

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