Clinical trial · Interventional
Preoperative vs Postoperative Hypofractionated Radiosurgery for Patients With Large Brain Metastases
Phase III Randomized Trial Comparing Preoperative Hypofractionated Radiosurgery (HSRS) to Postoperative Hypofractionated Radiosurgery (HSRS) for Patients With Large Brain Metastases (= 2.1cm) Suitable for Surgical Resection
NCT05545007CI-TRIAL-00109954SUPPORTrecruitingN/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)
This is a phase III randomized trial with the aim to compare preoperative HSRS to postoperative HSRS in patients with large at least one BMs from solid tumors suitable for surgical resection.
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, Adult | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brain metastases surgical resection | Procedure | — | UNRESOLVED |
| Hypofractionated Radiosurgery (HSRS) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HSRS pre-operative
- description
- Patients undergo HSRS (hypofractionated Radiosurgery) on day 1, consisting in 27 Gray (gy) administered in 3 daily fractions. Within 1 weeks, patients undergo surgical resection.
- interventionNames
- Radiation: Hypofractionated Radiosurgery (HSRS)
- Procedure: Brain metastases surgical resection
- type
- ACTIVE_COMPARATOR
- label
- HSRS post-operative
- description
- Patients undergo surgical resection on day 1. Within 4-6 weeks, patients undergo HSRS (hypofractionated Radiosurgery), consisting in 27 Gray (gy) administered in 3 daily fractions.
- interventionNames
- Radiation: Hypofractionated Radiosurgery (HSRS)
- Procedure: Brain metastases surgical resection
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years * Histological or cytological or radiological confirmation of solid tumor malignancy * Clinical indication for surgical resection of one brain metastasis * Karnosky performance status (KPS) ≥70 * Controlled or responsive extra cranial metastatic lesions * Limited brain metastases (1-4 BMs) * Single metastatic lesion ≥ 2.1 cm in maximum diameter (4 cm3) * Lesions ≤2 cm conditioning mass effect or neurological deficits or massive edema unresponsive to steroids * Written informed consent form Exclusion Criteria: * Prior WBRT * KPS \< 70 * Diagnosis of small cell lung cancer (SCLC), germinal cell tumour or Lymphoproliferative disease * Pregnant women * Prior open neurosurgery for malignancy * More than 4 brain metastases * Patients with incompatibility to perform MRI
References
Publications (0)
Data not yet available
No reference posted for this study.