NCT00875147

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2009

Shorter than P25 for all trials

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

October 25, 2016

Status Verified

January 1, 2010

Enrollment Period

4 months

First QC Date

April 2, 2009

Last Update Submit

October 24, 2016

Conditions

Colorectal Liver Metastases

Keywords

neoadjuvant chemotherapybevacizumab

Outcome Measures

Primary Outcomes (1)

  • Overall complications

    postoperative

Secondary Outcomes (1)

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

    postoperative

Study Arms (2)

with bevacizumab

Neoadjuvant chemotherapy with bevacizumab

Drug: bevacizumab

without Bevacizumab

Neoadjuvant chemotherapy without Bevacizumab

Interventions

bevacizumabDRUG

Neoadjuvant chemotherapy with bevacizumab

with bevacizumab

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients with neoadjuvant chemotherapy prior to liver resection

You may not qualify if:

  • Patients without neoadjuvant chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre de Chirurgie Viscérale et de Transplantation, Hautepierre Hospital

Strasbourg, Strasbourg, France

Location

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

Girona, Girona, Spain

Location

University Hospital of Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Stefan Breitenstein, MD

    Departement of Visceral and Transplantation Surgery of University hospital of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 2, 2009

First Posted

April 3, 2009

Study Start

April 1, 2009

Primary Completion

August 1, 2009

Study Completion

September 1, 2009

Last Updated

October 25, 2016

Record last verified: 2010-01

Locations

FR(1)ES(1)CH(1)