Phase II Study of 2-weekly RAILIRI Versus FOLFIRI as Second-line Treatment in Advanced Colorectal Cancer Patients

Sponsor
Fudan University
Study ID
NCT02376452
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Raltitrexed — DRUG
    2mg/m2 iv gtt, d1
  • 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 two-weekly RAILIRI regimen with FOLFIRI regimen in the treatment of advanced colorectal cancer patients in the second-line setting.

Key Dates

Start date
Sep 30, 2014
Status verified
Feb 2015
Primary completion
Dec 31, 2015
Completion
Dec 31, 2016

Study Design

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

Arms

  • Experimental: RALIRI
    Raltitrexed combined with irinotecan
  • Placebo Comparator: FOLFIRI
    5-fluorouracil,folinate combined with irinotecan

Primary Outcome Measure

progression free survival [ Time Frame: 2 months ]

Central Contacts

  • Wen Zhang
    8621-64175590-65242
  • Wenhua Li
    8621-64175590-65197

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