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

Colorectal Liver Metastases Clinical Trial

Official title:

Impact of Pre-operative Bevacizumab on Complications After Resection of Colorectal Liver Metastases A Case Matched Control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00875147
• Other study ID #: StV 12-2009
• Status: Completed
• Phase: N/A
• First received: April 2, 2009
• Last updated: October 24, 2016
• Start date: April 2009
• Est. completion date: September 2009

Study information

• Verified date: January 2010
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethic committee of Kanton Zurich,
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients with neoadjuvant chemotherapy prior to liver resection

Exclusion Criteria:

• Patients without neoadjuvant chemotherapy

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Colorectal Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• bevacizumab
Neoadjuvant chemotherapy with bevacizumab

Locations

Country	Name	City	State
France	Centre de Chirurgie Viscérale et de Transplantation, Hautepierre Hospital	Strasbourg
Spain	Division of hepato-biliary-pancreatic surgery. Department of surgery, "Josep Tureta" Hospital	Girona
Switzerland	University Hospital of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Countries where clinical trial is conducted

France,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall complications		postoperative	Yes
Secondary	specific complications such as liver insufficiency, length of hospital stay		postoperative	Yes