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Brief Title: Standard or Hypofractionated Radiotherapy Versus Accelerated Partial Breast Irradiation (APBI) for Breast Cancer
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
Study ID: NCT01247233
Brief 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.
Detailed Description: Following breast conservative surgery, patients will be stratified according to the following prognostic factors using a minimisation technique: age (\<70 vs ≥70), HER2 status (HER2+ vs HER2-), hormonal receptor status (RH+ vs RH-) and lymph node invasion (pN0 vs pN0i+). Patients will be allocated to receive either standard treatment, hypofractionated treatment or APBI. Radiation therapy should be started between 4 and 12 weeks after the last surgery. Patients treated with standard whole breast irradiation will receive a total dose of 50 Gy in 25 fractions, 2 Gy per day, 5 days a week. The boost of 16 Gy will be delivered in 8 fractions for all patients after completion of the 50 Gy, without interruption. All patients will receive one fraction per day, 5 fractions a week. Patients treated with hypofractionated irradiation will receive a total dose of either 40 Gy (in 15 fractions, 2.66 Gy per day) or 42.5 Gy (in 16 fractions, 2.65 Gy per day) 5 days a week. Patients treated with APBI will receive a total dose of 40 Gy in 10 fractions, delivered twice a day over a time period of 5-7 days. Each daily dose must be separated by 6 hours. Patients will be followed at 3 and 6 month after the last dose of irradiation, at 12 months after the date of last surgery and then on a yearly basis during 10 years.
Minimum Age: 50 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Centre de traitement des Hautes energie - Clinique de l'Europe, Amiens, , France
Centre Hospitalier Universitaire, Amiens, , France
Institut Bergonié, Bordeaux, , France
Centre Hospitalier, Brive, , France
Centre Francois Baclesse, Caen, , France
CH Chambery, Chambery, , France
Hopital Henri Mondor, Creteil, , 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
CRLC Val d'Aurelle, Montpellier, , France
Centre Hospitalier, Montélimar, , 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, Vandoeuvre les Nancy, , France
Institut Gustave Roussy, Villejuif, , France
Name: Yazid Belkacemi, MD PhD
Affiliation: Henri Mondor Hospital AP-HP, Créteil, France
Role: PRINCIPAL_INVESTIGATOR
Name: Eric Lartigau, MD
Affiliation: Oscar Lambret Hospital, Lille, France
Role: PRINCIPAL_INVESTIGATOR
Name: Céline Bourgier, MD
Affiliation: Institut de Cancérologie de Montpellier, Montpellier, France
Role: PRINCIPAL_INVESTIGATOR