NCT03697343

Fractionated Stereotactic Radiotherapy vs. Single Session Radiosurgery in Patients With Larger Brain Metastases

Efficacy and Safety of Fractionated Stereotactic Radiotherapy (FSRT) in Comparison to Single Session Radiosurgery in Patients With Larger Brain Metastases (2-4 cm)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 382 (estimated)
• Sponsor: University of Erlangen-Nürnberg Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase III trial comparing local control and side effects after fractionated stereotactic radiotherapy and single session radiosurgery in patients with larger brain metastases (2-4 cm)

Detailed description

This is a prospective, multicenter randomized trial comparing local control and side effects after fractionated stereotactic radiotherapy with 12 x 4 Gy and single session radiosurgery according to RTOG 9005 in patients with larger brain metastases (2-4 cm). Patients will be randomized to either fractionated stereotactic radiotherapy with 12 x 4 Gy or radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) as defined by the RTOG 9005. Randomization will be stratified by metastasis volume and histology.

Conditions

• Cerebral Metastases of Solid Cancers

Interventions

Type	Name	Description
RADIATION	Radiosurgery	Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm)
RADIATION	Fractionated stereotactic radiotherapy	Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm

Timeline

• Start date: 2021-05-18
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2018-10-05
• Last updated: 2022-12-13

Locations

13 sites across 1 country: Germany