Impact of Pre-Operative Bevacizumab on Complications After Resection of Colorectal Liver Metastases - Full Text View

Sponsored by:	University of Zurich
Information provided by:	University of Zurich
ClinicalTrials.gov Identifier:	NCT00875147

Purpose

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

Condition	Intervention
Colorectal Liver Metastases	Drug: bevacizumab

Drug Information available for: Bevacizumab

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Retrospective
Official Title:	Impact of Pre-Operative Bevacizumab on Complications After Resection of Colorectal Liver Metastases A Case Matched Control Study

Further study details as provided by University of Zurich:

Primary Outcome Measures:

Overall complications [ Time Frame: postoperative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

specific complications such as liver insufficiency, length of hospital stay [ Time Frame: postoperative ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	0
Study Start Date:	April 2009
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
with bevacizumab Neoadjuvant chemotherapy with bevacizumab	Drug: bevacizumab Neoadjuvant chemotherapy with bevacizumab
without Bevacizumab Neoadjuvant chemotherapy without Bevacizumab

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients, who underwent liver resection due to CRLM between 2005 and 2007, were retrospectively assessed for eligibility. Patients with chemotherapy containing Bev prior to surgery are identified consequtively. This group of patient with preoperative Bev is matched to patients without Bev.

Consecutive patients with neoadjuvant application of Bevacizumab will be matched to patients without Bevacizumab. Results are statistically adjusted according to potential confounders.

Criteria

Inclusion Criteria:

Patients with neoadjuvant chemotherapy prior to liver resection

Exclusion Criteria:

Patients without neoadjuvant chemotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875147

Contacts

Contact: Stefan Breitenstein, MD	0041 44 255 3041	stefan.breitenstein@usz.ch
Contact: Andreas Rickenbacher, MD	0041 44 255 11 11	andreas.rickenbacher@usz.ch

Locations

France
Centre de Chirurgie Viscérale et de Transplantation, Hautepierre Hospital
Strasbourg, France
Spain
Division of hepato-biliary-pancreatic surgery. Department of surgery, "Josep Tureta" Hospital
Girona, Spain
Switzerland
University Hospital of Zurich
Zurich, Switzerland, 8091

Sponsors and Collaborators

University of Zurich

Investigators

Principal Investigator:

Stefan Breitenstein, MD

Departement of Visceral and Transplantation Surgery of University hospital of Zurich

More Information

No publications provided

Responsible Party:	Department of Visceral and Transplantation Surgery, University Hospital Zurich ( Breitenstein Stefan, MD )
Study ID Numbers:	StV 12-2009
Study First Received:	April 2, 2009
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00875147 History of Changes
Health Authority:	Switzerland: Ethic committee of Kanton Zurich,

Keywords provided by University of Zurich:

neoadjuvant chemotherapy
bevacizumab

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms

Neoplasm Metastasis
Gastrointestinal Neoplasms
Bevacizumab
Angiogenesis Inhibitors

Additional relevant MeSH terms:

Liver Diseases
Digestive System Neoplasms
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Bevacizumab
Angiogenesis Inhibitors
Pharmacologic Actions
Liver Neoplasms

Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Neoplasm Metastasis
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on May 07, 2009