Description:
Selected patients with early stage breast cancer undergone conservative surgery were
randomized in two arms: Hypofractionated Whole Breast Irradiation versus Accelerated Partial
Breast Irradiation.
Title
- Brief Title: Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: WBI Versus APBI
- Official Title: Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: Adjuvant Hypofractionated Whole Breast Irradiation (WBI) Versus Accelerated Partial Breast Irradiation (APBI)
Clinical Trial IDs
- ORG STUDY ID:
1288
- NCT ID:
NCT02375048
Conditions
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Hypofractionated WBI | Active Comparator | Patients treated with hypofractionated Whole Breast Irradiation received Simultaneous Integrated Boost irradiation of the whole breast and surgical bed at two different dose levels using external intensity - modulated radiotherapy (VMAT RA). | |
Accelerated Partial Breast Irradiation | Experimental | Patients treated with Accelerated Partial Breast Irradiation received the irradiation on surgical bed using external intensity - modulated radiotherapy (VMAT RA). | |
Eligibility Criteria
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
Maximum Eligible Age: | 70 Years |
Minimum Eligible Age: | 55 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Toxicity will be measured with CTCAE v.4.0 |
Time Frame: | ten years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Rate of Local Control |
Time Frame: | ten years |
Safety Issue: | |
Description: | |
Measure: | Disease Free Survival |
Time Frame: | ten years |
Safety Issue: | |
Description: | |
Measure: | Overall Survival |
Time Frame: | ten years |
Safety Issue: | |
Description: | |
Measure: | Quality of Life Questionnaire |
Time Frame: | ten years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | Istituto Clinico Humanitas |
Last Updated
October 24, 2018