Tokyo, Feb. 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060696) titled 'A study to evaluate setup accuracy and patient preferences for radiotherapy performed under clothing' on Feb. 17.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - St. Luke's International University
Condition:
Condition - Breast cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this study is to prospectively evaluate the setup accuracy of markerless radiotherapy under clothing using surface-guided radiation therapy (SGRT), and to assess patient preferences for radiotherapy performed under clothing.
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - In this study, wearing clothing during radiotherapy is defined as the intervention. All radiotherapy delivery and image-guided procedures are conducted within the scope of routine clinical practice. Treatment dose, irradiation technique, and image guidance frequency are not modified from standard procedures.
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Female
Key inclusion criteria - 1) Patients with breast cancer scheduled to receive radiotherapy (whole-breast irradiation or accelerated partial breast irradiation) at our institution
2) Patients aged 20 years or older at the start of radiotherapy
3) Patients who have provided written informed consent to participate in this study
Key exclusion criteria - 1) Patients who decline to participate in this study or withdraw consent
Target Size - 80
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 17 Day
Anticipated trial start date - 2026 Year 04 Month 01 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=R000069426
Disclaimer: Curated by HT Syndication.