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

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00875147
First received: April 2, 2009
Last updated: January 22, 2010
Last verified: January 2010
  Purpose

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


Condition Intervention
Colorectal Liver Metastases
Drug: bevacizumab

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

Resource links provided by NLM:


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 ]

Estimated Enrollment: 0
Study Start Date: April 2009
Study Completion Date: September 2009
Primary Completion Date: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: Breitenstein Stefan, MD, Department of Visceral and Transplantation Surgery, University Hospital Zurich
ClinicalTrials.gov Identifier: NCT00875147     History of Changes
Other Study ID Numbers: StV 12-2009
Study First Received: April 2, 2009
Last Updated: January 22, 2010
Health Authority: Switzerland: Ethic committee of Kanton Zurich,

Keywords provided by University of Zurich:
neoadjuvant chemotherapy
bevacizumab

Additional relevant MeSH terms:
Neoplasm Metastasis
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014