Study to Assess the Efficacy and Safety of Treatment With FOLFIRI-aflibercept Compared to Initial Treatment With FOLFIRI-aflibercept (for 6 Cycles) Followed by Maintenance With 5FU-aflibercept, in an Elderly Population With mCRC After Failure of an Oxaliplatin-based Regimen

Sponsor
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Study ID
NCT03279289
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Aflibercept — DRUG
    4 mg/kg administered intravenous infusion on day 1
  • Irinotecan — DRUG
    180 mg/m2 intravenous infusion
  • folinic acid (dl racemic) — DRUG
    400 mg/m2 intravenous infusion
  • 5Fluorouracil — DRUG
    400 mg/m2 intravenous bolus
  • 5-FU — DRUG
    2400 mg/m2 continuous intravenous infusion over 46 hours

Study Details

The purpose of this study is to assess the efficacy and safety of treatment with FOLFIRI-aflibercept compared to initial treatment with FOLFIRI-aflibercept (for 6 cycles) followed by maintenance with 5FU-aflibercept, in an elderly population with metastatic colorectal cancer (mCRC) after failure of an oxaliplatin-based regimen

Key Dates

Start date
Oct 25, 2017
Status verified
Apr 2023
Primary completion
Feb 9, 2023
Completion
Feb 9, 2023

Study Design

Enrollment
170 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A
    INDUCTION PHASE: 6 cycles of FOLFIRI + aflibercept MAINTENANCE PHASE: 5FU/LV + aflibercept
  • Active Comparator: Group B
    FOLFIRI + aflibercept

Primary Outcome Measure

Progression-free survival [ Time Frame: 48 months ]

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