Status: Planned First registered on: 12/12/2019
Last updated on: 12/12/2019
1. Study identification
EU PAS Register NumberEUPAS32748
Official titleImpact of cardiovascular comorbidities on the effectiveness of bevacizumab in elderly patients with metastatic colorectal cancer
Study title acronymIRAZU
Study typeObservational study
Brief description of the studyColorectal cancer is the third most frequent cancer with a median age at diagnosis of 73 years. About 40% of cases evolve to a metastatic colorectal cancer (mCRC). The arrival of targeted therapies from 2005 in the therapeutic strategy of mCRC has participated to the improvement of overall survival for these patients. However, randomized controlled trials (RCTs) on mCRC suffer from an underrepresentation of elderly patients, while they represent the most part of mCRC patients. Despite this huge gap between the population included in RCTs and the population with mCRC, these RCTs are used to elaborate international guidelines. Owing to the mechanism of action of bevacizumab (angiogenesis inhibitor), cardiovascular adverse events such as heart failure, malignant hypertension, myocardial infarction, and venous and arterial thromboembolism are expected events, and frequently reported in RCTs. Despite the exclusion of patients with cardiovascular comorbidities from RCTs evaluating bevacizumab, the presence of cardiovascular comorbidities does not represent formal contraindications, but only precautions of use. Besides, there are no specific guidelines for the treatment of elderly patients, especially those with cardiovascular comorbidities, which are highly prevalent at mCRC diagnosis. To date, no data related to their impact on mCRC treatment by bevacizumab are available. This study aims to evaluate the impact of the presence of cardiovascular comorbidities on effectiveness and safety in elderly mCRC patients treated with bevacizumab. A cohort of mCRC patients aged ≥65 years at diagnosis, and treated with bevacizumab in first-line treatment will be identified between 2009 and 2015 using the French National Claims Database (SNDS). The primary endpoint will be defined as the occurrence of death from any cause at 36 months, and the secondary endpoints will be the occurrence of serious cardiovascular events during the follow-up.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameBordeaux university hospital
Centre locationBordeaux, France
Details of (Primary) lead investigator
Title Dr
Last name Gouverneur
First name Amandine
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?2

Bordeaux university hospital, Bordeaux, France
Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed04/07/2019
Start date of data collection01/09/2020
Start date of data analysis01/12/2020
Date of interim report, if expected
Date of final study report31/03/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyMinistère des Solidarités et de la Santé - Direction Générale de l'Offre de Soins – PHRC-K 2018100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Noize
First name Pernelle
Address line 1Bordeaux university hospital
Address line 2Department of clinical pharmacology 
Address line 3Hôpital Pellegrin, Place Amélie Raba-Léon 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)33547304319 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Dr 
Last name Gouverneur 
First name Amandine 
Address line 1Bordeaux university hospital 
Address line 2Department of clinical pharmacology 
Address line 3Hôpital Pellegrin, Place Amélie Raba-Léon 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)33557574672 
Alternative phone number 
Fax number (incl. country code) 
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