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Clinical Trials in the Netherlands / NCT05346367
Recruiting Not applicable

Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases

NCT05346367 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Haaglanden Medical Centre
Phase
Not applicable
Started
2022-07-18
Last updated
2024-03-12

Condition(s) studied

Brain Metastases

Investigational drug(s) / intervention(s)

SRTfSRT

SRT: SRT

fSRT: fSRT

Study 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 (SRT) in one or three fractions is compared to fractionated stereotactic radiotherapy (fSRT) in five fractions.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 * 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 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 (in field re-irradiation) * Presence of leptomeningeal metastases * Previous inclusion in the SAFESTEREO study

Primary outcome measure(s)

  • radio necrosis or local failure — 2 years after treatment
    Incidence of either radio necrosis or local failure according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM).

Trial sites (1)

FacilityCityRegionStatus
Haaglanden Medisch Centrum Leidschendam South Holland Recruiting

More Haaglanden Medical Centre trials in the Netherlands

Complement Inhibition: Attacking the Overshooting Inflammation @Fter Subarachnoid Hemorrhage (CIAO@SAH) Recruiting
Study on Prognosis of Acutely Ruptured Intracranial Aneurysms Active, not recruiting
Towards Optimal Treatment for High Risk Prostate Cancer Recruiting

Other trials for the same condition

Cryoablation of Brain Neoplasm Enrolling by invitation
Automated Detection of Brain Metastases on MRI Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05346367 on ClinicalTrials.gov ↗ ← All trials in the Netherlands