Status:
RECRUITING
Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases
Lead Sponsor:
Haaglanden Medical Centre
Conditions:
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 (S...
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 ...
Eligibility Criteria
Inclusion
- 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
- New brain metastases during follow-up after surgery allowed (when outside of resection cavity area)
- New brain metastases during follow-up after previous SRT allowed (when outside of previous irradiation field)
Exclusion
- 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 (in field re-irradiation)
- Presence of leptomeningeal metastases
- Previous inclusion in the SAFESTEREO study
Key Trial Info
Start Date :
July 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT05346367
Start Date
July 18 2022
End Date
March 1 2027
Last Update
March 12 2024
Active Locations (1)
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1
Haaglanden Medisch Centrum
Leidschendam, South Holland, Netherlands, 2262 BA