Actively Recruiting
Ultra-hypofractionated Radiotherapy in Breast Cancer Patients
Led by University Of Perugia · Updated on 2022-10-19
300
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ultra-hypofractionated Radiotherapy in Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients
- Age 63; 18 years
- Early stage breast cancer treated with breast conserving surgery
- Whole breast irradiation without regional nodal irradiation
- Infiltrating carcinomas
- CDIS
- Written informed consent
You will not qualify if you...
- Age <18 years
- Regional nodal radiotherapy
- Distant metastases
- Previous history of malignancy except basaloid skin tumours and CIN; previous breast cancer is allowed if treated curatively and disease free for at least 5 years
- Absolute radiotherapy contraindications such as pregnancy or inability to maintain treatment position
- Relative radiotherapy contraindications including active connective tissue diseases like rheumatoid arthritis, scleroderma, systemic lupus erythematosus, dermatomyositis, and vasculitis
- Patient's refusal to use data for research purposes
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Trial Site Locations
Total: 1 location
1
Radiation Oncology Section, Department of Medicine and Surgery, University of Perugia
Perugia, Italy, 06132
Actively Recruiting
Research Team
C
Cynthia Aristei, MD
CONTACT
I
Isabella Palumbo, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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