Efficacy of FOLFOX Versus FOLFOX Plus Aflibercept in K-ras Mutant Patients With Resectable Liver Metastases
Status:
Withdrawn
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
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
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC