RecruitingNCT05586256

Ultra-hypofractionated Radiotherapy in Breast Cancer Patients

Ultra-hypofractionated Adjuvant Radiotherapy After Breast Conserving Surgery in Breast Cancer Patients


Sponsor

University Of Perugia

Enrollment

300 participants

Start Date

Jul 21, 2021

Study Type

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

Sex: FEMALEMin Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether ultra-hypofractionated radiotherapy — delivering radiation in fewer, larger doses over a shorter period of time — is safe and effective for women with early-stage breast cancer who have had breast-conserving surgery (lumpectomy). **You may be eligible if...** - You are a woman aged 18 or older - You have early-stage breast cancer and have had a lumpectomy (breast-conserving surgery) - Your treatment plan involves whole breast radiation only (not including lymph node radiation) - You have either invasive breast cancer or DCIS (ductal carcinoma in situ) - You have signed informed consent **You may NOT be eligible if...** - You need radiation to include lymph nodes near the breast - Your cancer has spread to distant organs - You have had prior breast cancer treated within the last 5 years - You have a connective tissue disease (like lupus or scleroderma) or are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONultra-hypofractionated whole breast irradiation

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)

Radiation Oncology Section, Department of Medicine and Surgery, University of Perugia

Perugia, Italy

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NCT05586256


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