This trial is active, not recruiting.

Condition breast cancer
Treatments accelerated partial breast irradiation (apbi), whole breast irradiation (wbi)
Phase phase 3
Sponsor Azienda Ospedaliero-Universitaria Careggi
Start date March 2005
End date February 2014
Trial size 520 participants
Trial identifier NCT02104895, APBI-IMRT-Florence


The aim of this Phase 3 randomised trial is to compare the efficacy and safety of whole breast radiotherapy to accelerated partial breast irradiation using intensity-modulated radiotherapy technique in selected early breast cancer patients after breast conserving surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Conventional whole breast irradiation (WBI)
whole breast irradiation (wbi)
Conventional whole breast irradiation (WBI)
Accelerated partial breast irradiation (APBI)
accelerated partial breast irradiation (apbi)
Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)

Primary Outcomes

Ipsilateral breast tumor recurrence
time frame: 5-year

Secondary Outcomes

time frame: 5 years

Eligibility Criteria

Female participants at least 40 years old.

Inclusion Criteria: - Age at presentation >40 y - Tumor size <25 mm - Wide excision or quadrantectomy with clear margins (>5 mm) - Clips placed in tumor bed - Full informed consent from patient Exclusion Criteria: - Cardiac dysfunction - Forced expiratory volume in 1 second (FEV1) <1 L/m - Extensive intraductal carcinoma - Multifocal cancer - Psychiatric problems - Recurrent breast cancer

Additional Information

Official title Randomised Phase 3 Trial Of Accelerated Partial Breast Irradiation Using Intensity Modulated Radiotherapy Versus Whole Breast Irradiation
Principal investigator Lorenzo Livi, Full Prof
Description The surgeons were requested to place clips at the borders of the surgical bed, using a minimum of four clips. The presence of surgical clips was a selection criterion to avoid geographic misses. Computed tomography (CT) scanning was performed using 0.3-cm thick-slices and a slice spacing of 0.3 cm. In patients assigned to APBI arm, the clinical target volume (CTV) was drawn with a uniform 1-cm three-dimensional margin around the surgical clips. The CTV was limited to 3 mm from the skin surface and 3 mm from the lung-chest wall interface. A second uniform, three-dimensional 1-cm margin was added to the CTV to obtain the planning target volume (PTV). The PTV was allowed to extend 4 mm inside the ipsilateral lung and was limited to 3 mm from the skin. The ipsilateral and contralateral breast, ipsilateral and contralateral lung, heart, and spinal cord were contoured as organs at risk. All the regions of interest were contoured according to the International Commission on Radiation Units and Measurements reports 50 and 62 recommendations. No respiratory control was used. Concerning the experimental Arm (accelerated partial breast irradiation), a dose of 30 Gy in five fractions at 6 Gy/fraction was prescribed. The following constraints were adopted for plan optimization: PTV coverage: 100% of PTV covered by 95% of the prescribed dose (V28.5 = 100%); maximal dose to PTV <105% (31.5 Gy); minimal dose to PTV 28 Gy; uninvolved breast (i.e., ipsilateral breast without PTV): not >50% covered by a dose of >50% of the prescribed dose (V15 <50%); ipsilateral lung: not >20% covered by a dose >10 Gy (V10<20%); contralateral lung: not >10% covered by a dose >5 Gy (V5<10%); contralateral breast: maximal dose <1 Gy; heart: not >10% covered by a dose >3 Gy (V3 <10%).
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Azienda Ospedaliero-Universitaria Careggi.