To investigate clinical outcomes, late side effects, and cosmetic results of a single-fraction very accelerated partial breast irradiation as postoperative local treatment for the treatment of early stage breast cancer.
Accelerated Partial Breast Irradiation (APBI) has demonstrated the non-inferiority compared to external beam radiotherapy (EBRT) in the conserving-treatment of early breast carcinoma by using high-dose-rate (HDR) multicatheter interstitial brachytherapy (MIBT). The standard treatment regimen is 7-8 sessions with two treatments per day, for a total treatment time of 4-5 days. Based on 5-year results of the Groupe Européen de Curiethérapie European SocieTy for Radiotherapy \& Oncology (GEC-ESTRO) Very Accelerated Partial Breast Irradiation (VAPBI) phase I-II trial, in low-risk cases, 3-4 fractions delivered in 2 days reduced the overall treatment time with low rate of side effects and excellent oncological outcome. Retrospective and prospective studies with a single fraction HDR MIBT-based VAPBI suggest that by further increasing the dose delivered in one fraction, the total treatment time can be reduced to a single session safely. A phase II multicenter trial is proposed to confirm this hypothesis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Adjuvant accelerated partial breast brachytherapy, with interstitial multicatheter technique, in one fraction.
Centre Léon Bérard
Lyon, France
Five-year incidence of late grade ≥ 2 side effects
Radiation side effects based on Common Terminology Criteria for Adverse Events (CTCAE) (grade 1 to grade 5, higher score worse); and with the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/EORTC) Late Radiation Morbidity Scoring Schema (grade 1 to grade 4, higher score worse).
Time frame: From the third month of treatment to the end of the fifth year of follow-up.
Incidence (5-year actuarial rate) of ipsilateral breast recurrence (IBR)
Time frame: From treatment to the end of the fifth year of follow-up.
Incidence (5-year actuarial rate) of regional relapse (RR)
Time frame: From treatment to the end of the fifth year of follow-up.
Incidence (5-year actuarial rate) of contralateral breast cancer (CBC)
Time frame: From treatment to the end of the fifth year of follow-up.
Incidence (5-year actuarial rate) of distant metastasis (DM)
Time frame: From treatment to the end of the fifth year of follow-up.
Incidence (5-year actuarial rate) of any relapse (local, regional or distant, whichever came first) for disease free survival (DFS)
Time frame: From treatment to the end of the fifth year of follow-up.
Incidence (5-year actuarial rate) of breast cancer death for cause specific survival (CSS)
Time frame: From treatment to the end of the fifth year of follow-up.
Incidence (5-year actuarial rate) of death by any cause for overall survival (OS)
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Institut de Cancérologie de Lorraine
Nancy, France
NOT_YET_RECRUITINGAntoine Lacassagne Cancer Centre
Nice, France
RECRUITINGKlinikum Bremerhaven
Bremerhaven, Germany
NOT_YET_RECRUITINGUniversity Hospital Erlangen
Erlangen, Germany
RECRUITINGUniversitätsklinikum Schleswig-Holstein
Lübeck, Germany
NOT_YET_RECRUITINGSana Klinikum Offenbach
Offenbach, Germany
NOT_YET_RECRUITINGUniversitätsklinikum Würzburg
Würzburg, Germany
NOT_YET_RECRUITINGNational Institute of Oncology
Budapest, Hungary
RECRUITINGNational Cancer Institute
Vilnius, Lithuania
NOT_YET_RECRUITING...and 13 more locations
Time frame: From treatment to the end of the fifth year of follow-up.
Incidence of acute side effects
Radiation side effects based on Common Terminology Criteria for Adverse Events (CTCAE) (grade 1 to grade 5, higher score worse); and with the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/EORTC) Late Radiation Morbidity Scoring Schema (grade 1 to grade 4, higher score worse).
Time frame: From treatment to the end of the first 3 months of follow-up.
Cosmetic results at 5 years
Cosmetic results based on the Harvard criteria (excellent, good, fair, poor).
Time frame: From treatment to the end of the fifth year of follow-up.
Quality of Life (QoL)
European Organisation For Research And Treatment Of Cancer (EORTC) Quality of Life questionnaire (QLQ) C30 questionaire including the Breast cancer module (QLQ-BR23) (53 questions in total, from 1 to 4 points, higher score worse)
Time frame: From treatment to the end of the fifth year of follow-up.