New treatment method for brain metastases using fractionated stereotactic radiotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase II trial investigates a potentially safer treatment for brain metastases by comparing standard stereotactic radiotherapy (SRT) given in one or three fractions to fractionated stereotactic radiotherapy (fSRT) administered in five fractions. The study aims to reduce the incidence of radio necrosis, a significant long-term side effect, while monitoring survival rates, toxicity, and patient-reported quality of life. Participants will be closely monitored to assess the effectiveness and safety of the two treatment approaches.

Why it matters

Who can join: the full rules

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

Where it's running

• Haaglanden Medisch Centrum
  Leidschendam, South Holland, Netherlands Recruiting

Study contacts

• Principal investigator: Jaap D Zindler, MD, PhD — Haaglanden MC
• Study coordinator: Jaap D Zindler, MD, PhD
• Email: j.zindler@haaglandenmc.nl
• Phone: +31-88-9792013

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.