Observation of Patients With Metastatic Colorectal Cancer Starting Chemotherapy Combined With Bevacizumab (Avastin)
CONCERT
A Cohort Survey of Patients With Metastatic Colorectal Cancer Starting a Chemotherapy in Combination With Avastin®
1 other identifier
observational
765
1 country
1
Brief Summary
This is a longitudinal, multicenter, prospective, pharmacoepidemiological study to evaluate progression free survival (PFS) in a real-life setting in participants with metastatic colorectal cancer (mCRC) starting chemotherapy combined with bevacizumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2008
Longer than P75 for all trials
1 active site
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
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 19, 2015
CompletedFirst Posted
Study publicly available on registry
November 23, 2015
CompletedResults Posted
Study results publicly available
March 11, 2016
CompletedMarch 11, 2016
February 1, 2016
4.4 years
November 19, 2015
January 15, 2016
February 12, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival
Kaplan Meier estimates of median progression-free survival according to the metastatic line of treatment, for a median follow-up of 18, 15 and 13 months, respectively
within 36 months
Secondary Outcomes (2)
Overall Survival
Up to 36 months
Quality of Life - Global Health Status
Baseline, 6 and 12 months
Study Arms (1)
Observational Chemotherapy/Bevacizumab
Observed patients receiving chemotherapy with concomitant bevacizumab
Interventions
No intervention - Observational standard practice chemotherapy
No intervention - Observational concomitant bevacizumab
Eligibility Criteria
Patients with metastatic colorectal cancer (mCRC) starting chemotherapy combined with bevacizumab.
You may qualify if:
- Having received oral and written information about the survey and not objecting to having his/her data computerized
You may not qualify if:
- \- Participating in a clinical trial assessing an anticancer treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Neuilly-sur-Seine, 92521, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2015
First Posted
November 23, 2015
Study Start
May 1, 2008
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
March 11, 2016
Results First Posted
March 11, 2016
Record last verified: 2016-02