Efficacy of FOLFOX Versus FOLFOX Plus Aflibercept in K-ras Mutant Patients With Resectable Liver Metastases

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study ID
NCT01646554
Phase
PHASE2/PHASE3
Status
Withdrawn

Conditions

  • Colorectal Cancer Metastatic
  • KRAS Mutated Colorectal Cancer
  • Liver Metastases

Eligibility Criteria

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

Interventions

  • Modified FOLFOX6 — DRUG
  • Aflibercept — BIOLOGICAL
    Targeted therapy
  • Surgery — PROCEDURE

Study Details

Patients presenting with multiple innumerable liver metastases will probably never come to resection, however, for all others, including patients with numerous multiple metastases or large metastases, resection should be considered after limited chemotherapy. There is consensus for a backbone chemotherapy consisting of fluoropyrimidine + oxaliplatin. FOLFOX was used in the previous EORTC study and is again recommended. The addition of targeted agents to standard chemotherapy in the perioperative strategy for mCRC might increase the ORR and R0 resectability, without significant increase in toxicity, therefore translating to a better outcome. BOS2 (EORTC 40091) was designed to test this hypothesis in patients with a KRAS wold-type profile. It was decided in parallel to design an open label, randomized, multi-center, 2-arm phase II-III study this time aimed at enrolling KRAS mutated patients. Arm A: (standard) mFOLFOX6 + Surgery Arm B: (experimental) mFOLFOX6 + Aflibercept + Surgery

Key Dates

Start date
Dec 31, 2012
Status verified
May 2017
Primary completion
Dec 31, 2015
Completion
Dec 31, 2016

Study Design

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

Arms

  • Active Comparator: Arm A: modified FOLFOX6 and Surgery
    6 cycles before and 6 cycles after surgery consisting in: Hour 0: Oxaliplatin 85 mg/m² IV 2-h infusion Hour 0: Folinic Acid 400 mg/m² (DL form) or 200 mg/m2 (L form) IV 2-h infusion Hour 2: 5-FU 400 mg/m² IV bolus over 2-4 minutes Hour 2: 5-FU 2400 mg/m² given as a continuous infusion over 46h. On day 1 of a 14 day cycle
  • Experimental: Arm B: modified FOLFOX6 + Aflibercept and Surgery
    6 cycles before and 6 cycles after surgery consisting in: Hour 0: Aflibercept 4 mg/kg intravenous infusion 1-h Hour 1: Oxaliplatin 85 mg/m2 2-h infusion Hour 1: Folinic Acid 400 mg/m2 (DL form) or 200 mg/m2 (L form) 2-h infusion Hour 3: 5-FU bolus 400 mg/m2 IV bolus over 2-4 minutes Hour 3: 5-FU 2400 mg/m² given as a continuous infusion over 46h. Day 1 of a 14 day cycle Aflibercept should be given in all cycles, except cycle 6 of pre-operative treatment.

Primary Outcome Measure

Progression free survival [ Time Frame: 1 year ]

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