Self-Shielding Gyroscopic Radiosurgery – a First Prospective Observational Study and Retrospective Comparison.

• Conditions: C79.3; D35.2; Q28.2; D32; Q28.3; D33.3; D44.7; C69.3; C69.4; C71

• Registration Number: DRKS00025820
• Lead Sponsor: Europäisches Radiochirurgie Zentrum München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Legal age and radiographic (tumors) or histopathological (tumors) or clinical diagnosis (trigeminal neuralgia) of the listed diseases according to the ICD-10.

Exclusion Criteria

Nonage according to the definition of the Federal Republic of Germany

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
For tumors: local tumor control (according to the RECIST 1.1) at last follow-up<br>For trigeminal neuralgia: Visual Analogue Scale (VAS) for pain throughout the available follow-up

Secondary Outcome Measures

Name	Time	Method
Progression-free survival, overall survival, toxicity according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0) after treatment, quality of life at every follow-up (SF-12, according to the respective tumor: EORTC QLQ-BN20/QLQ-HN35 and QLQ-C30)