Tokyo, Sept. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058867) titled 'Patient-Reported Outcomes Following Hypo- vs Ultra-Hypofractionated Radiotherapy in Breast-Conserving Therapy: A Prospective Observational Study' on Sept. 11.

Study Type: Observational

Primary Sponsor: Institute - Kobe City Medical Center General Hospital

Condition: Condition - Breast cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - This study aims to compare acute adverse events and quality of life (QOL) after moderate hypofractionated (MHF) and ultra-hypofractionated (UHF) whole-breast irradiation in patients who have undergone breast-conserving surgery, using standardized assessment tools (PRO-CTCAE and CTCAE) from both patient-reported outcome (PRO) and clinician-reported outcome (CRO) perspectives. Basic objectives2 - Others

Eligibility: Age-lower limit - 40 years-old <= Age-upper limit - Not applicable Gender - Female Key inclusion criteria - 1.Female patients aged 40 years or older who have undergone breast-conserving surgery for early breast cancer and are scheduled to receive whole-breast irradiation 2.Female, 40 years of age or older 3.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 4.Written informed consent obtained from the patient Key exclusion criteria - 1.Patients requiring supraclavicular lymph node irradiation or boost irradiation 2.Patients scheduled to receive conventional fractionated radiotherapy (e.g., 50 Gy in 25 fractions) 3.History of prior radiotherapy to the same site 4.Presence of evident psychiatric disorders or cognitive impairment that may compromise the reliability of responses to questionnaires 5.Presence of comorbidities judged to have a significant impact on study endpoints 6.Determined by the attending physician to be unsuitable or unable to participate in the study Target Size - 100

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 09 Month 01 Day Date of IRB - 2025 Year 09 Month 03 Day Anticipated trial start date - 2025 Year 09 Month 03 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067252

Disclaimer: Curated by HT Syndication.