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Spots Global Cancer Trial Database for REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)

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Trial Identification

Brief Title: REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)

Official Title: REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity): Evaluation of Radiation-induced Cardiotoxicity of Adjuvant Radiotherapy With Tomotherapy for Breast Cancer

Study ID: NCT02079272

Study Description

Brief Summary: The purpose of this study is to determine whether a new technique of radiotherapy for breast cancer (helical tomotherapy) can induce cardiac toxicity that would be detected in the first two years after treatment. Screening of subclinical cardiac lesions with non-invasive cardiac imaging techniques combined with measures of circulating biomarkers of cardiac tissue lesions and coronary lesions would allow assessing radiation-induced cardiac toxicity at an early stage.

Detailed Description: REBECCA study will consist in a monocentric prospective cohort that will include 120 women volunteers treated with adjuvant tomotherapy for breast cancer in the Institut Regaud Claudius-Toulouse (ICR) and followed for 2 years after radiotherapy. In summary, women aged between 40 and 70 years, surgically treated at ICR for breast cancer and for whom adjuvant radiotherapy with tomotherapy is indicated, with no indication of chemotherapy will be eligible for the study.

Eligibility

Minimum Age: 40 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Institut Claudius Regaud, Toulouse, , France

Contact Details

Name: Carole Massabeau, MD

Affiliation: Institut Claudius Regaud, Toulouse (France)

Role: PRINCIPAL_INVESTIGATOR

Name: Marie-Odile Bernier, MD

Affiliation: Institut de Radioprotection et de Sureté Nucléaire, Fontenay-aux-Roses (France)

Role: PRINCIPAL_INVESTIGATOR

Name: Jean Ferrières, MD, PhD

Affiliation: University Hospital Rangueil, Toulouse (France)

Role: PRINCIPAL_INVESTIGATOR

Name: Hervé Rousseau, MD, PhD

Affiliation: University Hospital Rangueil, Toulouse (France)

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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