Clinical trial · Interventional
Stereotactic Radiotherapy of Resection Cavity For Single Brain Metastasis Versus Whole-Brain Radiotherapy After Resection
Phase 3 Study of Stereotactic Radiotherapy of the Postoperative Resection Cavity Versus Whole-Brain Irradiation After Surgical Resection of Single Brain Metastasis
- 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)
Adjuvant whole-brain radiation therapy (WBRT) after resection of single brain metastasis is considered as a standard associated with side effects leading to decreased neurocognitive function. The Investigators addressed the question whether stereotactic radiotherapy of the resection cavity impairs neurological status and/or cognitive functions in compare to adjuvant WBRT.
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 |
|---|---|---|---|
| stereotactic body radiotherapy (SBRT) | Radiation | — | UNRESOLVED |
| Whole-Brain Radiotherapy (WBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SBRT to resection cavity
- description
- 18Gy in 1 fraction for resection cavity \<2cm in maximum diameter, 15Gy in 1 fraction for resection cavity 2.1-3cm in maximum diameter, 15Gy in 1 fraction or 25 Gy in 5 fractions over 5 days for resection cavity 3.1-4cm in maximum diameter, 25 Gy in 5 fractions over 5 days for resection cavity \>4cm in maximum diameter
- interventionNames
- Radiation: stereotactic body radiotherapy (SBRT)
- type
- ACTIVE_COMPARATOR
- label
- WBRT
- description
- 30Gy in 10 fractions over 12 days to whole brain
- interventionNames
- Radiation: Whole-Brain Radiotherapy (WBRT)
Primary outcomes (1)
- measure
- Failure-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with surgically removed histologically proven metastatic cancer * Subtotal or total resection of single brain metastasis * Presence of single brain metastasis in MRI * Karnofsky Performance Status ≥ 70 * Life expectancy \> 6 months (minimal extracranial disease or availability of effective oncology treatment) * No previous history of cranial irradiation * Availability of MRI * Starting radiotherapy within six weeks after neurosurgery * Negative pregnancy test for woman * Written informed consent Exclusion Criteria: * Dementia and central nervous system diseases leading to higher risk of radiation toxicity * Contraindications for MRI and/or no patient's tolerance and acceptance of cranial MRI * Altered level of consciousness * Histologically proven metastatic small cell lung cancer
References
Publications (0)
Data not yet available