NCT05346367 Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases
| NCT ID | NCT05346367 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Haaglanden Medical Centre |
| Condition | Brain Metastases |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2022-07-18 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2022-07-18 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (SRT) in one or three fractions is compared to fractionated stereotactic radiotherapy (fSRT) in five fractions.
Eligibility Criteria
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
Contact & Investigator
Jaap D Zindler, MD, PhD
PRINCIPAL INVESTIGATOR
Haaglanden MC
Frequently Asked Questions
Who can join the NCT05346367 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Metastases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05346367 currently recruiting?
Yes, NCT05346367 is actively recruiting participants. Contact the research team at j.zindler@haaglandenmc.nl for enrollment information.
Where is the NCT05346367 trial being conducted?
This trial is being conducted at Leidschendam, Netherlands.
Who is sponsoring the NCT05346367 clinical trial?
NCT05346367 is sponsored by Haaglanden Medical Centre. The principal investigator is Jaap D Zindler, MD, PhD at Haaglanden MC. The trial plans to enroll 130 participants.