Study of 5-Fluorouracil/Leucovorin/Oxaliplatin (FOLFOX) + Bevacizumab Versus 5-Fluorouracil/Leucovorin/Oxaliplatin/Irinotecan (FOLFOXIRI) + Bevacizumab as First Line Treatment of Patients With Metastatic Colorectal Cancer Not Previously Treated and With Three or More Circulating Tumoral Cells

Sponsor
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Study ID
NCT01640405
Phase
PHASE3
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • modified FOLFOX6 + bevacizumab — DRUG
    * Bevacizumab 5 mg/kg iv, day 1, followed by * Oxaliplatin 85 mg/m2 iv administered over a period of 2 hours, day 1, followed by * 5- Fluorouracil (FU)/Leucovorin (LV), day 1 and 2, as follow: * LV 400 mg/m2 iv administered over a period of 2 hours, followed by * 5-FU 400 mg/m2 iv bolus, followed by * 5-FU 2.400 mg/m2 over 46 h continuous infusion. This treatment will start on day 1 and will be repeated every 2 weeks (1 cycle).
  • FOLFOXIRI + Bevacizumab — DRUG
    * Bevacizumab 5 mg/kg iv, followed by * Irinotecan 165 mg/m2 iv administered over a period of 30-90 minutes, followed by * Oxaliplatin 85 mg/m2 iv administered over a period of 2 hours, followed by * LV 400 mg/m2 iv administered over a period of 2 hours, followed by * 5-FU 3,200 mg/m2 for 48 h continuous infusion. This treatment will start on day 1 and will be repeated every 2 weeks (1 cycle).

Study Details

The purpose of the study is to evaluate FOLFOX + bevacizumab versus FOLFOXIRI + bevacizumab as first line treatment of patients with metastatic colorectal cancer not previously treated and with three or more circulating tumoral cells.

Key Dates

First listed
Jul 13, 2012
Start date
Jul 31, 2012
Status verified
Apr 2019
Primary completion
Nov 30, 2018
Completion
Nov 30, 2018

Study Design

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

Arms

  • Active Comparator: Control
    modified FOLFOX6 + bevacizumab
  • Experimental: Experimental
    FOLFOXIRI+bevacizumab

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: 5 years ]

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