Observation of Patients With Metastatic Colorectal Cancer Starting Chemotherapy Combined With Bevacizumab (Avastin)

Metastatic Colorectal Cancer Clinical Trial

— CONCERT  

Official title:

A Cohort Survey of Patients With Metastatic Colorectal Cancer Starting a Chemotherapy in Combination With Avastin®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612077
• Other study ID #: ML21696
• Status: Completed
• Phase: N/A
• First received: November 19, 2015
• Last updated: February 12, 2016
• Start date: May 2008
• Est. completion date: October 2012

Study information

• Verified date: February 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 765
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Having colon or rectal metastatic adenocarcinoma, for which the physician decided during the inclusion visit to start a treatment with bevacizumab combined with a 1st, 2nd or 3rd line chemotherapy

• Having received oral and written information about the survey and not objecting to having his/her data computerized

Exclusion Criteria:

• Participating in a clinical trial assessing an anticancer treatment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Other:
• Observational Chemotherapy
No intervention - Observational standard practice chemotherapy

Drug:
• Concomitant Bevacizumab
No intervention - Observational concomitant bevacizumab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Overall Survival	Overall Survival (OS) was defined as the time between the treatment start (date of the first infusion of bevacizumab) and death from any cause. Kaplan Meier estimates of median overall survival were calculated for the metastatic lines of treatment, with a median follow-up of 18, 15 and 13 months, respectively.	Up to 36 months	No
Secondary	Quality of Life - Global Health Status	Participants rated their quality of life (global health status) on the European Organization for Research and Treatment of Cancer 30-item Core Quality of Life Questionnaire (EORTC QLQ C-30), with total scores ranging from 0 (worst) to 100 (best).	Baseline, 6 and 12 months	No