Study Comparing Pathological Responses Observed on Colorectal Cancer Metastases Resected After Preoperative Treatment Combining Cetuximab With FOLFOX or FOLFIRI in RAS and B-RAF WT Tumors

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study ID
NCT01858662
Phase
PHASE2
Status
Terminated

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Metastases Resection ( multiple steep surgery possible) — PROCEDURE
    Metastases resection will be process by surgery, after a randomized chemotherapy (FOLFOX or FOLFIRI) + Target therapy (Cetuximab). The surgery will allow to compare the pathological response on the resected metastases by the chemotherapy + target therapy type.
  • 5-Fluorouracile — DRUG
    5-FU bolus 400 mg/m2, IV bolus every 2 weeks 5-FU continuous infusion 2400 mg/m2, 46-hour cont. IV infusion every 2 weeks
  • leucovorin L — DRUG
    Leucovorin L (levoleucovorin) 200 mg/m2 (or folinic acid 400 mg/m²) in 250 ml glucose 5%, 2-hour IV infusion
  • Oxaliplatin — DRUG
    Oxaliplatin 85 mg/m² in 150 ml NaCl 0.9%, 2-hour IV infusion every 2 weeks
  • Irinotecan — DRUG
    Irinotecan 180 mg/m² in 150 ml NaCl 0.9%, 1.30-hour IV infusion every 2 weeks
  • Cetuximab — DRUG
    Cetuximab 400 mg/m² in 100 ml NaCl 0.9% 2-hour IV infusion for 1rst cycle and after the 1rst cycle 250 mg/m² in 100 ml NaCl 0.9% 1-hour IV infusion

Study Details

To analyze the pathological tumor response on resected colorectal cancer metastases after preoperative treatment with cetuximab combined with FOLFOX or FOLFIRI regimen in a prospective cohort (RAS and B-RAF WT tumors) and to correlate this response with patient's outcome.

Key Dates

Start date
Jan 31, 2014
Status verified
Apr 2016
Primary completion
Nov 30, 2015
Completion
Nov 30, 2015

Study Design

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

Arms

  • Active Comparator: oxaliplatin +leucovorin L+5FU+ cetuximab
    oxaliplatin +leucovorinL+5-Fluorouracile +cetuximab+'Metastases Resection ( multiple steep surgery possible)
  • Active Comparator: Irinotecan+ + leucovorinL +5-Fluorouracil +cetuximab
    Irinotecan+ + leucovorinL +5-Fluorouracile + cetuximab +'Metastases Resection ( multiple steep surgery possible)

Primary Outcome Measure

Major Pathological Response Rate [ Time Frame: Average 3 months (after resection of metastases) ]

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