NCT05346367

Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Haaglanden Medical Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomized phase II trial. The study aims to investigate a different and potentially safer radio therapeutic treatment method for brain metastases. The current standard of stereotactic radiotherapy (SRT) in one or three fractions is compared to fractionated stereotactic radiotherapy (fSRT) in five fractions.

Detailed description

Randomized phase II trial. Stereotactic radiotherapy is one of the most frequently chosen treatment options for brain metastases. There are an increasing number of long term survivors. Brain necrosis (e.g. radio necrosis) is the most important long term side effect of the treatment, occurring in up to 40% of patients, dependent on the size of the metastasis and delivered radiotherapy dose. Retrospective studies have shown that the incidence of radio necrosis, as well as local tumor recurrence, can be decreased with a risk difference of around 20% by administrating fractionated stereotactic radiotherapy (fSRT, e.g. five fractions) over single fraction stereotactic radiotherapy, especially in large brain metastases. In this trial, one group is treated with SRT in one or three fractions. The other group is treated with fSRT in five fractions. Survival, toxicity and patient reported quality of life are monitored.

Conditions

• Brain Metastases

Interventions

Type	Name	Description
RADIATION	SRT	SRT
RADIATION	fSRT	fSRT

Timeline

• Start date: 2022-07-18
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2022-04-26
• Last updated: 2024-03-12

Locations

1 site across 1 country: Netherlands