Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061042) titled 'Ultra-Hypofractionated Sequential Boost Following Ultra-Hypofractionated Whole-Breast Irradiation After Breast-Conserving Surgery: A Phase II Safety Study (UPBEAT-Boost Trial)' on April 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Historical
Primary Sponsor:
Institute - Kobe City Hospital Organization, Kobe City Medical Center General Hospital (Clinical Departments I, II, and III)
Condition:
Condition - Breast Cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the safety of a radiation regimen consisting of ultra-hypofractionated whole-breast irradiation (26 Gy in 5 fractions over 5 days) followed by a sequential boost irradiation (5.2 Gy in 1 fraction over 1 day) in patients requiring boost irradiation after breast-conserving surgery.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Ultra-hypofractionated whole-breast irradiation (26 Gy in 5 fractions over 5 days) followed by sequential boost irradiation (5.2 Gy in 1 fraction over 1 day) after breast-conserving surgery.
Eligibility:
Age-lower limit - 20
years-old
=20 years.
7) Performance status (ECOG) of 0 or 1.
8) No prior history of radiotherapy to the chest. However, prior irradiation to the contralateral breast is permitted.
9) Written informed consent for participation in the study is obtained from the patient.
Key exclusion criteria - 1) Presence of active multiple primary cancers (synchronous cancers or metachronous cancers with a disease-free interval of =38 C.
4) Pregnant women, women who may be pregnant, or women who are breastfeeding.
5) Presence of psychiatric disease or psychiatric symptoms judged to make participation in the study difficult.
6) Diabetes mellitus requiring continuous insulin treatment or poorly controlled diabetes mellitus (HbA1c >=7.0% as a guideline).
7) Presence of interstitial pneumonia, pulmonary fibrosis, or severe emphysema.
8) Continuous systemic steroid therapy (oral or intravenous).
9) Receiving immunosuppressive therapy due to active collagen disease.
10) History of any of the following: severe heart disease, heart failure, myocardial infarction within 6 months, or angina attack within 6 months.
11) Cases judged by the principal investigator or sub-investigator to be unsuitable for participation in this study.
Target Size - 45
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 03 Month 01 Day
Date of IRB - 2026 Year 03 Month 17 Day
Anticipated trial start date - 2026 Year 03 Month 23 Day
Last follow-up date - 2033 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069708
Disclaimer: Curated by HT Syndication.
