Ultra-hypofractionated Radiotherapy in Breast Cancer Patients
Ultra-hypofractionated Adjuvant Radiotherapy After Breast Conserving Surgery in Breast Cancer Patients
University Of Perugia
300 participants
Jul 21, 2021
OBSERVATIONAL
Conditions
Summary
The present multicenter, retrospective and prospective observational study, aims to evaluate an ultra-hypofractionated whole breast irradiation schedule (WBI, 26 Gy in 5 fractions), in order to confirm literature data (FAST-F study) in the clinical practice. Patient population included women affected by early stage breast cancer (BC), both invasive and ductal carcinoma in situ, receiving ultra-hypofractionated WBI (with or without a tumor bed boost) after breast conserving surgery (BCS). Main exclusion criteria are mastectomy and regional nodal irradiation. Neoadjuvant and/or adjuvant systemic therapies are allowed. The primary otcome is acute and chronic toxicity evaluation. Secondary outcomes are: overall servival (OS), disease-free survival (DFS), rates of local and loco-regional recurrences, distant metastasis occurrence, cosmetic outcome and quality of life (QoL) assessment. Acute and late toxicities will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) scale version 5.0. Cosmetic assessment will be graded according to the Harvard scale. Frontal photographs of both breasts will be used to evaluate toxicity and cosmetic results. For QoL assessment the EORTC (European Organisation for Research and Treatment of Cancer), QLQ-C30 and EORTC-QLQ-BR23 questionnaires will be administered.
Eligibility
Inclusion Criteria7
- Female patients
- Age ≥ 18 years.
- Early stage breast cancer treated with breast conserving surgery
- Whole breast irradiation without regional nodal irradiation
- Infiltrating carcinomas
- CDIS
- Written informed consent
Exclusion Criteria5
- Age\<18 years.
- Regional nodal radiotherapy.
- Distant metastases.
- Presence of absolute radiotherapy contraindications (pregnancy, inability to maintain the correct treatment position) and relative radiotherapy contraindications (connective tissue diseases including rheumatoid arthritis, scleroderma, systemic lupus erythematosus, dermatomyositis and vasculitis, especially if the disease is in an active phase)
- Patient's refusal to use data for research purposes.
Interventions
All enrolled patients will be treated with an ultra-ipofractionated whole breast irradiation schedule (26 Gy delivered in 5 consecutive fractions, single dose 5.2 Gy), according to FAST-Forward trial. Whole bresat irradiation should be followed or not by a tumor bed boost (sequential: 7.6 Gy in 2 consecutive fractions, single dose 3.8 Gy or simultaneous intergrated boost: 30 Gy in 5 consecutive fractions, single dose 6 Gy). Either three-dimensional conformal radiotherapy (3DCRT), intensity-modulated radiotherapy (IMRT), volumetric modulated arc therapy (VMAT) or helicoildal techniques are allowed. Breath control techniques may be used at the discretion of each partecipating centre. Main exclusion critereria are mastectomy and regional nodal irradiation. Neoadjuvant and/or adjuvant systemic therapies are allowed.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05586256