Comparing two types of radiotherapy for brain metastases after surgery
Hypofractionated Stereotactic Radiotherapy Versus Single Fraction Stereotactic Radiosurgery to the Resection Cavity of Brain Metastases After Surgical Resection - A Prospective, Randomized, Controlled, Monocentric Phase III Trial
This study is testing whether a new type of radiation treatment for brain tumors after surgery works better than the standard method for helping patients keep their tumors under control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Technical University of Munich Academic / other |
| Locations | 1 site (Munich, Bavaria) |
| Trial ID | NCT05160818 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of hypofractionated stereotactic radiotherapy (HFSRT) versus single fraction stereotactic radiosurgery (SRS) for patients who have undergone surgical resection of brain metastases. A total of 126 patients will be randomly assigned to receive either HFSRT or SRS, with the primary goal of determining which method provides better local control of the tumor at the resection site after 12 months. The study will utilize advanced imaging techniques and follow-up assessments to monitor patient outcomes and ensure safety. The trial aims to clarify the optimal radiation treatment approach for this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with one to three resected brain metastases and a performance status of KPS greater than 60%.
Not a fit: Patients with leptomeningeal disease, hematological malignancies, or those who have previously received brain irradiation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved local control of brain metastases, enhancing patient outcomes and survival rates.
How similar studies have performed: Previous studies have shown promising results with both HFSRT and SRS, but this specific comparison in a randomized controlled setting is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed solid tumor disease * One to three resected brain metastases * Consent to perform adjuvant irradiation by an interdisciplinary tumor board * Completed wound healing * Resection within the last six weeks at the time of study inclusion * Diameter of the resection cavity ≤ 4 cm (on Planning MRI) * Age \> 18 years * KPS \> 60% * Adequate contraceptive measures for fertile women / men * Written informed consent (must be available before enrolment in the trial) Exclusion Criteria: * Contraindication for repetitive contrast enhanced MRI * Leptomeningeal disease * Small cell histology, hematological malignancies and / or germ cell malignancies * Previous irradiation of the brain * Pregnant and lactating women * Inability to understand the character and consequences of the study * Withdrawal of consent
Where this trial is running
Munich, Bavaria
- Dept. Radiation Oncology — Munich, Bavaria, Germany (Recruiting)
Study contacts
- Study coordinator: Maria Waltenberger
- Email: maria.waltenberger@mri.tum.de
- Phone: +49-89-4140-8281
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.