FOLFIRI Versus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer Patients

Sponsor
Fudan University
Study ID
NCT02935764
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    180 mg/m2 iv gtt, d1
  • 5-fluorouracil — DRUG
    5-FU 400mg/m2 iv, 2400mg/m2 civ 46h
  • Leucovorin — DRUG
    400mg/m2 iv gtt,d1

Study Details

This study is designed to compare the efficacy and safety of FOLFIRI regimen with irinotecan monodrug in the treatment of advanced colorectal cancer patients in the second-line setting.

Key Dates

Start date
Oct 31, 2016
Status verified
Oct 2016
Primary completion
Oct 31, 2019

Study Design

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

Arms

  • Experimental: FOLFIRI
    5-fluorouracil,folinate combined with irinotecan
  • Active Comparator: IRINOTECAN
    irinotecan

Primary Outcome Measure

progression free survival [ Time Frame: 2 months ]

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