Study Comparing Pathological Responses Observed on Colorectal Cancer Metastases Resected After Preoperative Bevacizumab With FOLFOX or FOLFIRI.

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study ID
NCT01858649
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Metastases resection — PROCEDURE
    Surgery of colorectal cancer metastases will be proceeded after 3 to 6 cycles of chemotherapy ( folfox or folfiri) + bevacizumab .
  • Bevacizumab — DRUG
    Bevacizumab 5 mg/kg in 100 ml NaCl 0.9% IV infusion 3 to 5 cycles. No bevacizumab for ultimate cycle .
  • 5 FU — DRUG
    Leucovorin L (levoleucovorin) 200 mg/m2 (or folinic acid 400 mg/m²) in 250 ml glucose 5%, IV infusion 3 to 6 cycles 5-FU bolus 400 mg/m2, IV bolus 3 to 6 cycles 5-FU continuous infusion 2400 mg/m2, 46-hour cont. IV infusion 3 to 6 cycles
  • Oxaliplatin — DRUG
    oxaliplatin 85 mg/m² in 150 ml NaCl 0.9%, IV infusion 3 to 6 cycles
  • Irinotecan — DRUG
    Irinotecan 180 mg/m² in 150 ml NaCl 0.9%, IV infusion 3 to 6 cycles

Study Details

The study is designed to analyze the pathological tumor response on resected colorectal cancer metastases after preoperative treatment with bevacizumab combined with FOLFOX or FOLFIRI regimen in a prospective cohort and to correlate this response with patient's outcome.

Key Dates

Start date
May 31, 2013
Status verified
Oct 2020
Primary completion
May 31, 2019
Completion
May 31, 2019

Study Design

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

Arms

  • Active Comparator: Folfox: oxaliplatin +leucovorin+ 5FU
    FOLFOX (oxaliplatin +leucovorin+ 5FU) +bevacizumab+ metastases resection
  • Active Comparator: FOLFIRI: irinotecan+leucovorin+5FU
    FOLFIRI (irinotecan+leucovorin+5FU) +bevacizumab +metastases resection

Primary Outcome Measure

the major pathological response rate [ Time Frame: After surgery (Metastases resection-average 3 months) ]

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