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OpenTrials
Completed

NCT Number: NCT02612077

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

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.

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Neuilly-sur-Seine, 92521, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational Chemotherapy

Other

No intervention - Observational standard practice chemotherapy

Concomitant Bevacizumab

Drug

No intervention - Observational concomitant bevacizumab

Other names: Avastin

Primary outcomes

  1. Progression-free Survival

    Time frame: within 36 months

    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

Secondary outcomes

  1. Overall Survival

    Time frame: Up to 36 months

    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.

  2. Quality of Life - Global Health Status

    Time frame: Baseline, 6 and 12 months

    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).

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Acronym: CONCERT

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Nov 23, 2015
Registry last updated
Mar 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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