FOLFIRI or mFOLFOX6 in Adjuvant Chemotherapy in Advanced Colorectal Cancer

Sponsor
Sun Yat-sen University
Study ID
NCT01566942
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Oxaliplatin — DRUG
    In this arm, patients will receive the adjuvant chemotherapy with mFOLFOX6 regimen for 8 cycles. Oxaliplatin 85mg/m2, day1, every 2 weeks; Leucovorin 200mg/m2,day1,every 2 weeks;5-FU 400mg/m2,iv, day1, 5-FU 3.0g/m2, bolus for 46h,every 2 weeks
  • Irinotecan — DRUG
    In this arm, patients will receive the adjuvant chemotherapy with FOLFIRI regimen for 8 cycles. Irinotecan 180mg/m2, day1, every 2 weeks; Leucovorin 200mg/m2,day1,every 2 weeks;5-FU 400mg/m2,iv, day1, 5-FU 3.0g/m2, bolus for 46h,every 2 weeks

Study Details

the aim of this study is to observe the effect of irinotecan-based regimen in patients with advanced colorectal cancer.

Key Dates

Start date
Jun 30, 2012
Status verified
Mar 2012
Primary completion
May 31, 2014
Completion
Jun 30, 2017

Study Design

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

Arms

  • Active Comparator: FOLFOX
    In this group, the patients will receive the adjuvant chemotherapy with mFOLFOX6.
  • Experimental: FOLFIRI
    in this arm, patients will receive adjuvant chemotherapy with FOLFIRI regimen for about 8 cycles

Primary Outcome Measure

disease-free survival（DFS） [ Time Frame: 3-year disease-free survival rate ]

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