Folfox-B Study for Patients With Colorectal Liver Metastases
Status:
Terminated
Trial end date:
2009-06-01
Target enrollment:
Participant gender:
Summary
Objective:
- To evaluate the efficacy of the use of the combination of oxaliplatin, 5-fluorouracil,
leucovorin and bevacizumab (FOLFOX-B) in patients with unresectable colorectal liver
metastases, with the objective to downstage hepatic disease and enable complete
resection of residual disease.
Primary Objective:
- To evaluate the resection rate in patients with initially unresectable hepatic
colorectal metastases downstaged with FOLFOX-B. Complete resection of all liver lesions
is the goal.
Secondary Objectives:
- To evaluate the probability of complete response, partial response or stable disease.
- To evaluate the proportion of patients who are resected, and the proportion of patients
achieving an R0 resection (among those receiving surgery).
- To correlate survival with downstaging and resection based on metastatic colorectal
prognostic score.
- To evaluate the disease-free survival and overall survival.
- To evaluate the positron emission tomography response rate.
- To explore correlations of clinical response with telomerase and hTERT expression.