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. It was therefore decided to design an open label, randomized, multi-center, 3-arm late phase II study. Arm A: (standard) mFOLFOX6 + Surgery Arm B: (experimental) mFOLFOX6 + Bevacizumab + Surgery Arm C: (experimental) mFOLFOX6 + Panitumumab + Surgery
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
5-FU, folinic acid, oxaliplatin
Targeted therapy
Targeted therapy
Allgemeines Krankenhaus der Stadt Wien
Vienna, Austria
Hopital Universitaire Brugmann
Brussels, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
AZ Groeninge Kortrijk - Campus Kennedylaan
Kortrijk, Belgium
AZ Turnhout - Campus Sint Elisabeth
Turnhout, Belgium
Centre Hospitalier Peltzer-La Tourelle
Verviers, Belgium
Institut Sainte Catherine
Avignon, France
Institut Bergonie
Bordeaux, France
CHU Ambroise Pare
Boulogne-Billancourt, France
Assistance Publique - Hôpitaux de Paris - Hopital De Bicetre AP-HP
Le Kremlin-Bicêtre, France
...and 15 more locations
Progression free survival
Increase in progression free survival rate at 1 year in each experimental arm (mFOLFOX6 + bevacizumab or panitumumab) compared to mFOLFOX6 alone arm.
Time frame: 1 year
Pathological response rate
Increase in major pathological response rate between mFOLFOX6 alone arm and each experimental arm.
Time frame: 4 years
Resection rate
Compare the percentage of patients with total resection with these three treatments.
Time frame: 4 years
Overall survival
Overall survival is defined as the time interval between the date of randomization and the date of death. Patients who are still alive when last traced will be censored at the date of last follow-up.
Time frame: 8 years
Safety
All adverse events will be recorded; the investigator will assess whether those events are drug related (reasonable possibility, no reasonable possibility) and this assessment will be recorded in the database for all adverse events.
Time frame: 4 years
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