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Clinical Trials/NCT00875147
NCT00875147CompletedNot Applicable

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

University of Zurich3 sites in 3 countries163 target enrollmentStarted: April 2009Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
163
Locations
3
Primary Endpoint
Overall complications

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients with neoadjuvant chemotherapy prior to liver resection

Exclusion Criteria

  • Patients without neoadjuvant chemotherapy

Arms & Interventions

with bevacizumab

Neoadjuvant chemotherapy with bevacizumab

Intervention: bevacizumab (Drug)

Outcomes

Primary Outcomes

Overall complications

Time Frame: postoperative

Secondary Outcomes

  • specific complications such as liver insufficiency, length of hospital stay(postoperative)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ksenija Slankamenac

MD

University of Zurich

Study Sites (3)

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