Improving therapeutic ratio with hypofractionated stereotactic radiotherapy for brain metastases.

Phase 2

Recruiting

• Conditions: brain metastasis; 10009720; cancer spread in the brain; 10027476

• Registration Number: NL-OMON56002
• Lead Sponsor: Haaglanden Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 130

Inclusion Criteria

- Age >= 18 years
- At least one brain metastasis of large cell cancer suitable for SRT
- Karnofsky Performance Status >= 70
- Ability to provide written informed consent
- Previous systemic therapy for brain metastases allowed
- New brain metastases during follow-up after surgery allowed (outside
resection cavity)

Exclusion Criteria

- Contra-indication for MRI scan
- Primary tumor of small cell lung cancer, germinoma or lymphoma
- Prior whole brain radiotherapy or SRT on the current target brain metastases
(BM) (in field re-irradiation; salvage SRT of non-irradiated BM allowed if
radiation dose from previous irradiation in current target field is <1.0 Gy)
- The presence of leptomeningeal metastases
- Previous inclusion in the SAFESTEREO study
-Active bleeding metastases

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the incidence of adverse local event (either<br /><br>radionecrosis or local failure according to RANO) at 2 year post-radiotherapy<br /><br>with respect to baseline</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Survival<br /><br>- Quality of life<br /><br>- Seizure outcome<br /><br>- Toxicity</p><br>