Clinical trial · Interventional
Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases
NCT05346367CI-TRIAL-00074944SAFESTEREOrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fSRT | Radiation | — | UNRESOLVED |
| SRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- SRT (stereotactic radiotherapy)
- description
- stereotactic radiotherapy in 1 or 3 fractions of 8 Gy up to 15-24 Gy
- interventionNames
- Radiation: SRT
- type
- EXPERIMENTAL
- label
- fSRT (hypo fractionated stereotactic radiotherapy)
- description
- hypo fractionated stereotactic radiotherapy in 5 fractions of 7 Gy up to 35 Gy. Brain stem metastases 5 fractions of 6 Gy up to 30 Gy
- interventionNames
- Radiation: fSRT
Primary outcomes (1)
- measure
- radio necrosis or local failure
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDCrouzen JA, Petoukhova AL, Broekman MLD, Fiocco M, Fisscher UJ, Franssen JH, Gadellaa-van Hooijdonk CGM, Kerkhof M, Kiderlen M, Mast ME, van Rij CM, Nandoe Tewarie R, van de Sande MAE, van der Toorn PPG, Vlasman R, Vos MJ, van der Voort van Zyp NCMG, Wiggenraad RGJ, Wiltink LM, Zindler JD. SAFESTEREO: phase II randomized trial to compare stereotactic radiosurgery with fractionated stereotactic radiosurgery for brain metastases. BMC Cancer. 2023 Mar 25;23(1):273. doi: 10.1186/s12885-023-10761-1. PMID 36964529