Tokyo, Oct. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063184) titled 'A Multi-institutional Prospective Observational Study of hypofractionated whole breast radiotherapy with Simultaneous Integrated Boost for Breast conservation surgery' on Oct. 6.
Study Type:
Observational
Primary Sponsor:
Institute - Aichi Cancer Center Hospital
Condition:
Condition - Breast cancer (after breast-conserving surgery)
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the feasibility and safety of hypofractionated whole breast radiotherapy with simultaneous integrated boost (SIB) using intensity-modulated radiotherapy after breast-conserving surgery in routine clinical practice in Japan, and to describe the actual dose-volume parameters.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Female
Key inclusion criteria - 1) Age 18 years or older.
2) Underwent breast-conserving surgery for primary breast cancer (invasive carcinoma or DCIS).
3) Whole breast irradiation plus tumor bed boost is indicated as adjuvant radiotherapy.
4) To receive hypofractionated IMRT with simultaneous integrated boost (SIB).
5) Oral informed consent obtained.
Key exclusion criteria - 1) Distant metastasis (stage IV).
2) Previous radiotherapy to the ipsilateral breast or chest.
3) Regional nodal irradiation (supraclavicular, axillary or internal mammary) is planned.
4) Hereditary disorders with radiosensitivity, or active collagen vascular disease (e.g., scleroderma, systemic lupus erythematosus) that contraindicates or poses a high risk for radiotherapy.
5) Pregnant or possibly pregnant.
6) Difficulty in obtaining consent or in evaluation for medical or other reasons.
Target Size - 100
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 04 Month 07 Day
Date of IRB - 2026 Year 04 Month 07 Day
Anticipated trial start date - 2026 Year 04 Month 30 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072315
Disclaimer: Curated by HT Syndication.
