Pre- and Postoperative Chemotherapy Including Bevacizumab in Potentially Curable Metastatic Colorectal Cancer
Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
Summary
Major attempt is being given to the potential of curing patients with metastatic colorectal
cancer due to the recognition of dramatic change in survival figures achieved in palliative
chemotherapy combination treatment protocols. Achieving resectablity rates in previously
unresectable patients has been defined as study endpoint among other well known primary and
secondary objectives. Curing metastatic colorectal cancer is most likely in resectable
patients and therefore the logical next step after completion of chemotherapy combination
studies (e.g. EORTC 40983) is the addition of targeted agents. Bevacizumab has the most valid
data of improving outcome figures and was therefore chosen as additional agent. Safety of the
combination with Xelox was demonstrated in the investigators pilot trial (Gruenberger JCO
2006, ASCO 2006, WCGC 2006, ESMO 2006), consequently response rate and resection rate will be
the primary endpoints in this trial.
STUDY OBJECTIVES
Primary Objective The primary objective of this study is the Resectability (R0) rate after
neoadjuvant Bevacizumab in potentially resectable mCRC.
Secondary Objectives The secondary objectives of this study include
- Feasibility with regards to GI bleeding and wound healing complications after surgery of
liver metastases
- General safety
- Overall Response Rate (ORR)
- Recurrence Free Survival (RFS)
- Overall Survival (OS)
STUDY DURATION Recruitment is planned for 12 months. Patients will be treated for 6 cycles
XELOX and 5 cycles Bevacizumab. Surgery will be performed 2 weeks after the last Capecitabine
administration, allowing a time window of 5 weeks between the last Bevacizumab administration
and surgery.
Therapy with 6 cycles of XELOX and Bevacizumab will be restarted 4-5 weeks after surgery.
With a Follow up period of 2 years after the last enrolled patient, in order to assess RFS
and OS, the trial will last for approx. 3 years.
NUMBER OF CENTRES Four centres with a high level of experience in the surgery of liver
metastases are planned to participate in this study.
SELECTION CRITERIA
Total Number of Patients and Target Population The planned total sample size for this study
is 43 patients. Patients with potentially resectable metastatic colorectal cancer previously
untreated for metastatic disease will be enrolled in this trial.