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

University of Erlangen-Nürnberg Medical School

Status and phase: Enrolling; Phase 3

Conditions: Cerebral Metastases of Solid Cancers

Treatments: Radiation: Radiosurgery; Radiation: Fractionated stereotactic radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03697343

FSRT-Trial

Details and patient eligibility

About

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)

Full 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.

Enrollment: 382 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years, no upper age limit
• Karnofsky Performance Score > 50 points
• Expected Survival > 3 months
• 1-10 cerebral metastases of metastatic solid cancer
• Indication for local radiotherapy
• Patients must be able to understand the protocol and provide informed consent

Exclusion criteria

• Whole Brain radiotherapy no longer than 6 weeks before the start of stereotactic radiotherapy or planned whole brain radiotherapy after stereotactic radiotherapy
• Prior irradiation of the cerebral metastasis that is to be treated in the study
• Relevant overlap of prior radiation fields with the metastasis that is to be treated in the study
• Metastasis in the brainstem
• Contraindication for cerebral MRI
• Metastasis that is to be treated in the study can't be visualized in contrast-enhanced T1 MRI sequence
• Pregnant or lactating women
• Abuse of illicit drugs, alcohol or medication
• Patient not able or willing to behave according to protocol
• Participation in another clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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382 participants in 2 patient groups

Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) and

Other group

Description:

Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm) and no margin as defined by the RTOG 9005

Treatment:

Radiation: Radiosurgery

Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm

Other group

Description:

Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm margin

Treatment:

Radiation: Fractionated stereotactic radiotherapy