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ACTIVE NOT RECRUITING
NCT01247233
NA

Standard or Hypofractionated Radiotherapy Versus Accelerated Partial Breast Irradiation (APBI) for Breast Cancer

Sponsor: UNICANCER

View on ClinicalTrials.gov

Summary

The standard treatment for localized breast cancer is based on conservative surgery (when possible) followed by radiation therapy (RT) delivered to the whole breast. The recommended total RT dose is 45 to 50 Gy delivered in 4.5 to 5 weeks followed by a 10 to 16 Gy boost to the tumor bed for 1 to 1.5 weeks. The rationale for the development of APBI was based on the difficulty for many patients to reach RT centers to receive standard whole breast irradiation (WBI) after conservative surgery. APBI offers decreased overall treatment time and several theoretical advantages over WBI, including a decrease in dose delivered to uninvolved portions of the breast and adjacent organs. If equivalence between the two treatments can be shown, then APBI will be considered as a historic evolution in breast cancer management. In this phase III trial, designed in postmenopausal women \>50 years of age, the objective is to compare the effectiveness and safety of APBI compared with whole breast irradiation. This study is also designed to ensure high quality criteria for surgery, pathology and RT techniques in the 3 arms and will allow to provide data on economics and costs.

Official title: Phase III Multicentric Trial Comparing Accelerated Partial Breast Irradiation (APBI) Versus Standard or Hypofractionated Whole Breast Irradiation in Low Risk of Local Recurrence of Breast Cancer

Key Details

Gender

FEMALE

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1006

Start Date

2010-12-27

Completion Date

2025-10

Last Updated

2025-05-14

Healthy Volunteers

No

Interventions

RADIATION

Whole Breast Irradiation + Boost or Hypofractionated irradiation

Whole Breast Irradiation 50 Gy + Boost 16 Gy or Whole breast, either 40 Gy in 15 fractions in 3 weeks or 42.5 Gy in 16 fractions in 3 weeks

RADIATION

Accelerated partial breast irradiation

Tumor bed 40 Gy in 10 fractions, 2 fractions of 4 Gy per day in 5 to 7 days.

Locations (34)

Centre de traitement des Hautes energie - Clinique de l'Europe

Amiens, France

Centre Hospitalier Universitaire

Amiens, France

Institut Bergonié

Bordeaux, France

Centre Hospitalier

Brivé, France

Centre Francois Baclesse

Caen, France

CH Chambery

Chambéry, France

Hopital Henri Mondor

Créteil, France

Centre Leonard de Vinci

Dechy, France

CHU Michallon

Grenoble, France

Hôpital Robert Boulin

Libourne, France

Centre Oscar Lambret

Lille, France

CHU Dupuytren

Limoges, France

Centre Léon Bérard

Lyon, France

Institut Paoli Calmettes

Marseille, France

Clinique du Pont de Chaume

Montauban, France

Centre Hospitalier

Montélimar, France

CRLC Val d'Aurelle

Montpellier, France

Centre Hospitalier de Mulhouse

Mulhouse, France

Centre d'Oncologie de Gentilly

Nancy, France

Clinique Hartmann

Neuilly-sur-Seine, France

Centre de Haute Energie

Nice, France

Groupe Hospitalier Pitié Salpétrière

Paris, France

Hopital Tenon

Paris, France

Saint Louis Hospital

Paris, France

Centre Catalan d'Oncologie

Perpignan, France

Institut Jean Godinot

Reims, France

Centre Eugène Marquis

Rennes, France

CH de Roanne

Roanne, France

Centre Henri Becquerel

Rouen, France

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, France

Centre Paul Stauss

Strasbourg, France

Centre Marie Curie

Valence, France

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, France

Institut Gustave Roussy

Villejuif, France