Pre- and Postoperative Chemotherapy Including Bevacizumab in Potentially Curable Metastatic Colorectal Cancer

Sponsor
Austrian Society Of Surgical Oncology
Study ID
NCT00444041
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    neoadjuvant therapy prior to elective surgery

Study Details

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.

Key Dates

First listed
Mar 7, 2007
Start date
Jan 31, 2007
Status verified
Jan 2013
Primary completion
Dec 31, 2009
Completion
Dec 31, 2009

Study Design

Enrollment
43 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Xelox, Bev

Primary Outcome Measure

The primary objective of this study is the Resectability (R0) rate after neoadjuvant Bevacizumab in potentially resectable mCRC. [ Time Frame: 4 months ]

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