Cancer of Breast
Conditions
Brief summary
Selected patients with early stage breast cancer undergone conservative surgery were randomized in two arms: Hypofractionated Whole Breast Irradiation versus Accelerated Partial Breast Irradiation.
Detailed description
Patients treated with Hypofractionated Whole Breast Irradiation (WBI) received SIB irradiation of the whole breast and surgical bed at two different dose levels. Dose prescription was 40.5 Gy to PTVWB and 48.0 Gy to PTVboost in 15 fractions over 3 weeks, with simultaneous integrated boost delivering 2.7 and 3.2Gy/fraction for each PTV respectively. Daily image guided radiotherapy (IGRT) were generated before each treatment session in each patient to verify the set-up. Accelerated Partial Breast Irradiation (APBI) using external intensity -modulated radiotherapy (VMAT RA) was delivered at a dose of 30 Gy in five 6-Gy/day fractions over 10 days (every other day) with IGRT at each treatment.
Interventions
RADIATIONHypofractionated WBI
Dose prescription was 40.5 Gy to PTVWB and 48.0 Gy to PTVboost in 15 fractions over 3 weeks, with simultaneous integrated boost delivering 2.7 and 3.2Gy/fraction for each PTV respectively. Daily image guided radiotherapy (IGRT) were generated before each treatment session in each patient to verify the set-up.
RADIATIONAccelerated Partial Breast Irradiation
APBI was delivered at a dose of 30 Gy in five 6-Gy/day fractions over 10 days (every other day) with IGRT at each treatment.
Sponsors
Istituto Clinico Humanitas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 55\< Age \<70 * Tumor size ≤ 2 cm * pN0 (SN biopsy or ALND) * ER/PgR positive * Margins \> 5 mm (either at initial surgery or at re-excision) * Clips placed in the surgical bed (minimum of 4 clips) * Unicentric only * No lymphovascular invasion * Any grade * No extensive intraductal component (\>25%) * Written informed consent
Exclusion criteria
* Prior thoracic radiation therapy * Oncoplastic surgery / No clips in the surgical bed * Multicentric cancer * Autoimmune disease, vasculitis, collagenopathy or scleroderma that may predispose to late sequelae
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity will be measured with CTCAE v.4.0 | ten years |
| Cosmesis will be measured with Harvard scale | ten years |
Secondary
| Measure | Time frame |
|---|---|
| Rate of Local Control | ten years |
| Disease Free Survival | ten years |
| Overall Survival | ten years |
| Quality of Life Questionnaire | ten years |
Countries
Italy
Outcome results
None listed