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

NCT ID: NCT00875147

Last Updated: 2016-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

163 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Colorectal Liver Metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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with bevacizumab

Neoadjuvant chemotherapy with bevacizumab

bevacizumab

Intervention Type DRUG

Neoadjuvant chemotherapy with bevacizumab

without Bevacizumab

Neoadjuvant chemotherapy without Bevacizumab

No interventions assigned to this group

Interventions

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bevacizumab

Neoadjuvant chemotherapy with bevacizumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with neoadjuvant chemotherapy prior to liver resection

Exclusion Criteria

* Patients without neoadjuvant chemotherapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Ksenija Slankamenac

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan Breitenstein, MD

Role: PRINCIPAL_INVESTIGATOR

Departement of Visceral and Transplantation Surgery of University hospital of Zurich

Locations

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Centre de Chirurgie Viscérale et de Transplantation, Hautepierre Hospital

Strasbourg, Strasbourg, France

Site Status

Division of hepato-biliary-pancreatic surgery. Department of surgery, "Josep Tureta" Hospital

Girona, Girona, Spain

Site Status

University Hospital of Zurich

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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France Spain Switzerland

Other Identifiers

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StV 12-2009

Identifier Type: -

Identifier Source: org_study_id

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