- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00875147
Impact of Pre-operative Bevacizumab on Complications After Resection of Colorectal Liver Metastases
Impact of Pre-operative Bevacizumab on Complications After Resection of Colorectal Liver Metastases A Case Matched Control Study
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Strasbourg, France
- Centre de Chirurgie Viscérale et de Transplantation, Hautepierre Hospital
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Girona, Spain
- Division of hepato-biliary-pancreatic surgery. Department of surgery, "Josep Tureta" Hospital
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Zurich, Switzerland, 8091
- University Hospital of Zürich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with neoadjuvant chemotherapy prior to liver resection
Exclusion Criteria:
- Patients without neoadjuvant chemotherapy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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with bevacizumab
Neoadjuvant chemotherapy with bevacizumab
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Neoadjuvant chemotherapy with bevacizumab
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without Bevacizumab
Neoadjuvant chemotherapy without Bevacizumab
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Overall complications
Time Frame: postoperative
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postoperative
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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specific complications such as liver insufficiency, length of hospital stay
Time Frame: postoperative
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postoperative
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stefan Breitenstein, MD, Departement of Visceral and Transplantation Surgery of University hospital of Zurich
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms
- Neoplasms by Site
- Digestive System Neoplasms
- Liver Diseases
- Neoplastic Processes
- Neoplasm Metastasis
- Liver Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
Other Study ID Numbers
- StV 12-2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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