NCT03775330

Radiosurgery With or Without Whole Brain Radiation for Multiple Metastases

Parallel Prospective Observational Cohorts Evaluating Stereotactic Radiosurgery Alone (SRS) and Whole Brain Radiotherapy (WBRT) Plus SRS for Patients With 5 to 30 Brain Metastases

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 126 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical study is a parallel, prospective observational single-centre trial in patients presenting with 5 to 30 brain metastases. Patients to receive either stereotactic radiosurgery (SRS) alone or SRS plus whole brain radiation (WBRT) will be enrolled.

Detailed description

The current standard of care for patients with limited brain metastases (1 to 4) is stereotactic radiosurgery (SRS) alone. This has evolved from the traditional standard of care in treating patients with whole brain radiation (WBRT). Studies in patients with limited (less than 5) brain metastases have shown that WBRT is harmful with respect to neurocognition and does not improve patient survival compared to SRS alone. As a result, SRS alone now is considered the standard of care treatment for patients with limited metastases. However, there is a lack of high quality prospective randomized evidence on the role of SRS in patients with 5 or more brain metastases to guide treatment. Therefore, this study seeks to prospectively compare SRS alone versus SRS plus WBRT in patients with 5 to 30 brain metastases.

Conditions

• Brain Metastases

Interventions

Type	Name	Description
RADIATION	Stereotactic Radiosurgery (SRS)	SRS or hypofractionated stereotactic radiation delivered via the Leksell Gammknife Perfexion/Icon radiosurgery system. Hypofractionated stereotactic radiotherapy 25-32.5 Gy in 5 fractions or 24-27 Gy in 3 fractions at the discretion of the radiation oncologist Maximum diameter of metastasis (doses in single fraction): ≤ 2 cm: 15-20 Gy \> 2 cm and ≤ 3 cm: 15-18 Gy \> 3 cm and ≤ 4 cm: 15 Gy Tumour location (doses in single fraction): Brainstem: 15 Gy Hypofractionated stereotactic radiotherapy 25-32.5 Gy in 5 fractions may be used for lesions \> 2 cm at the discretion of the radiation oncologist Note: SRS dosing reduced by 20% (for all prescriptions \> 15 Gy) when patient is randomized to SRS + WBRT arm
RADIATION	Whole brain radiation (WBRT)	WBRT 20 Gy in 5 fractions or 30 Gy in 10 fractions at the discretion of the radiation oncologist

Timeline

• Start date: 2020-10-20
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2018-12-13
• Last updated: 2025-05-18

Locations

1 site across 1 country: Canada