Tokyo, Aug. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058644) titled 'A Multicenter Retrospective Study Comparing Radiosurgical Techniques for Large Brain Metastases Treated with Gamma Knife Radiosurgery (Japanese Leksell Gamma Knife Society 2501 Study)' on Aug. 4.
Study Type:
Observational
Primary Sponsor:
Institute - NTT Medical Center Tokyo
Condition:
Condition - brain metastases
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To improve treatment outcomes for large brain metastases, two- or three-stage radiosurgery - administered with inter-fraction intervals of several weeks - has been employed as an alternative to conventional single-session gamma knife radiosurgery. In recent years, technological advancements have enabled the implementation of consecutive fractionated radiosurgery at many gamma knife centers. However, robust evidence regarding its efficacy and safety remains limited. The present study aims to retrospectively analyze a cohort of domestic cases to evaluate the validity of fractionated radiosurgery in terms of both efficacy and safety, primarily through comparison with two- or three-stage radiosurgery.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients who underwent gamma knife radiosurgery for brain metastases with a tumor volume of 4 cm3 or more between January 1, 2016, and December 31, 2024, will be included
Key exclusion criteria - The patient has previously undergone other treatments or interventions for brain metastases, such as surgical resection, cyst drainage, or whole-brain radiotherapy.
Karnofsky Performance Status (KPS) is below 70% (if neurological symptoms caused by brain metastases are present, the pre-symptom KPS is below 70%).
The number of brain metastases exceeds 10.
Contrast-enhanced MRI was not obtained for treatment planning.
There is evidence of cerebrospinal fluid dissemination.
No post-treatment contrast-enhanced MRI has been obtained, or post-treatment imaging status is unknown.
The primary tumor is classified as carcinoma of unknown origin, sarcoma, or lymphoma.
Target Size - 300
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 07 Month 23 Day
Date of IRB - 2025 Year 07 Month 23 Day
Anticipated trial start date - 2025 Year 07 Month 24 Day
Last follow-up date - 2025 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067026
Disclaimer: Curated by HT Syndication.
