Impact of Pre-operative Bevacizumab on Complications After Resection of Colorectal Liver Metastases

Completed

• Conditions: Colorectal Liver Metastases
• Interventions: Drug: bevacizumab

• Registration Number: NCT00875147
• Lead Sponsor: University of Zurich

Brief Summary

Hypothesis of the study: Neoadjuvant chemotherapy with Bevacizumab impairs postoperative outcome after resection of colorectal liver metastases.

Detailed Description

Bevacizumab is a humanized monoclonal antibody against vascular endothelial growth factor (VEGF) increasingly added to other drugs in the treatment of colorectal cancer. Bev is typically used in combination with other chemotherapeutic agents such as oxaliplatin, irinotecan, leucovorin and 5-fluorouracil (5-FU) for treatment of patients with CRLM. The objective of this study was to assess the impact of neoadjuvant bevacizumab on clinical outcome after hepatectomy of colorectal liver metastases (CRLM).

Patients, who underwent liver resection due to colorectal liver metastases after neoadjuvant chemotherapy, operated between 2005 and 2007 will be evaluated retrospectively. The patients will be distributed in two groups, either with or without bevacicumab. Outcome parameters are mortality, complications, hospital stay and ICU stay. To increase the power of the study the total number of patients will be increased by adding patients from other centers. Results will be adjusted for the propensity of developing complications.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-02
• Study First Submitted QC: 2009-04-02
• Study First Posted: 2009-04-03
• Primary Completion: 2009-08
• Study Completion: 2009-09
• Status Verified: 2010-01
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

Inclusion Criteria

• Patients with neoadjuvant chemotherapy prior to liver resection

Exclusion Criteria

• Patients without neoadjuvant chemotherapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
with bevacizumab	bevacizumab	Neoadjuvant chemotherapy with bevacizumab

Primary Outcome Measures

Name	Time	Method
Overall complications	postoperative

Secondary Outcome Measures

Name	Time	Method
specific complications such as liver insufficiency, length of hospital stay	postoperative

Trial Locations

Locations (3)

Centre de Chirurgie Viscérale et de Transplantation, Hautepierre Hospital; 🇫🇷 Strasbourg, France

University Hospital of Zurich; 🇨🇭 Zurich, Switzerland

Division of hepato-biliary-pancreatic surgery. Department of surgery, "Josep Tureta" Hospital; 🇪🇸 Girona, Spain