Trials / Terminated
TerminatedNCT01508000
Efficacy of FOLFOX Alone, FOLFOX Plus Bevacizumab and FOLFOX Plus Panitumumab in Patients With Resectable Liver Metastases
Randomized Phase II Trial Evaluating the Efficacy of FOLFOX Alone, FOLFOX Plus Bevacizumab and FOLFOX Plus Panitumumab as Perioperative Treatment in Patients With Resectable Liver Metastases From Wild Type KRAS/NRAS Colorectal Cancer
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC · Network
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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. 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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FOLFOX6 | 5-FU, folinic acid, oxaliplatin |
| BIOLOGICAL | Bevacizumab | Targeted therapy |
| BIOLOGICAL | Panitumumab | Targeted therapy |
| PROCEDURE | Surgery |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2016-09-01
- Completion
- 2016-09-01
- First posted
- 2012-01-11
- Last updated
- 2016-10-12
Locations
25 sites across 6 countries: Austria, Belgium, France, Netherlands, Spain, Switzerland
Source: ClinicalTrials.gov record NCT01508000. Inclusion in this directory is not an endorsement.