New treatment method for brain metastases using fractionated stereotactic radiotherapy
Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases
This study is testing a new way to treat brain metastases using a different form of radiation therapy to see if it can reduce side effects while still helping patients live longer and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Haaglanden Medical Centre Academic / other |
| Locations | 1 site (Leidschendam, South Holland) |
| Trial ID | NCT05346367 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with at least one brain metastasis from large cell cancer who are suitable for stereotactic radiotherapy.
Not a fit: Patients with small cell lung cancer, germinoma, lymphoma, or those who have previously undergone whole brain radiotherapy or SRT on the current target metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes and reduced side effects for patients with brain metastases.
How similar studies have performed: Retrospective studies have suggested that fractionated stereotactic radiotherapy may reduce the risk of radio necrosis and local tumor recurrence, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leidschendam, South Holland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.