Pre- and Postoperative Chemotherapy Including Bevacizumab in Potentially Curable Metastatic Colorectal Cancer (ASSO-LM1)
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.
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.
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pre- and Postoperative Chemotherapy Including Bevacizumab in Potentially Curable Metastatic Colorectal Cancer (mCRC). A Multicenter, Single Arm Phase I/II Academic Trial|
- The primary objective of this study is the Resectability (R0) rate after neoadjuvant Bevacizumab in potentially resectable mCRC. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Feasibility with regards to GI bleeding and wound healing complications after surgery of liver metastases [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- Overall Response Rate (ORR) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Recurrence Free Survival (RFS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Overall Survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
|Experimental: Xelox, Bev||
neoadjuvant therapy prior to elective surgery
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|Medical University Hospital Vienna|
|Vienna, Austria, 1090|
|Principal Investigator:||Thomas Gruenberger, MD||Austrian Society Of Surgical Oncology|