Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: WBI Versus APBI
NCT ID: NCT02375048
Last Updated: 2018-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
179 participants
INTERVENTIONAL
2015-01-19
2018-02-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hypofractionated WBI
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).
Hypofractionated 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.
Accelerated Partial Breast Irradiation
Patients treated with Accelerated Partial Breast Irradiation received the irradiation on surgical bed using external intensity - modulated radiotherapy (VMAT RA).
Accelerated 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.
Interventions
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Hypofractionated 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.
Accelerated 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Oncoplastic surgery / No clips in the surgical bed
* Multicentric cancer
* Autoimmune disease, vasculitis, collagenopathy or scleroderma that may predispose to late sequelae
55 Years
70 Years
FEMALE
No
Sponsors
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Istituto Clinico Humanitas
OTHER
Responsible Party
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Michele Tedeschi
MD
Principal Investigators
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Marta Scorsetti, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto Clinico Humanitas
Locations
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Istituto Clinico Humanitas
Rozzano, Milano, Italy
Countries
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Other Identifiers
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1288
Identifier Type: -
Identifier Source: org_study_id
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