Clinical trial · Interventional
Local Radiotherapy Following Complete Resection of a Brain Metastasis
Postoperative Local Stereotactic Radiotherapy Versus Observation Following a Complete Resection of a Single Brain Metastasis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Too limited accrual
Summary
Brief summary (as posted)
Objective: To improve local control following complete resection of a single brain metastasis using fractionated local stereotactic radiotherapy, whilst maintaining neurological functioning, neurocognition and quality of life. Study design: Multicenter randomized phase III, with at least three high-volume Dutch centers participating in the trial. Stratification on primary tumor type and age. Study population: Patients undergoing complete resection of a single brain metastasis, confirmed by an early (i.e. within 72 hours) postoperative contrast-enhanced MR scan. Study intervention: Patients will be randomized between observation alone (standard arm) and local stereotactic radiotherapy in three fractions of 8 Gy to the surgical cavity (study arm). Main study parameters: Primary objective: local control rate at 6 months. Secondary objectives: local control rate at 12 months, neurological functioning, freedom from clinical neurological progression, performance status, quality of life, toxicity, steroid use, neurocognition and overall survival.
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 Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| local SRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- observation
- description
- Watchful waiting
- type
- ACTIVE_COMPARATOR
- label
- local stereotactic radiotherapy (SRT)
- description
- local SRT in three fractions of 8 Gy to the surgical cavity
- interventionNames
- Radiation: local SRT
Primary outcomes (1)
- measure
- local control rate
- timeFrame
- at 6 months
- description
- as assessed on follow-up MRI scans
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age of 18 years or older. * Radiologically confirmed complete resection of a single brain metastasis on a contrast-enhanced MRI within 72 h after resection. * Primary solid tumor, excluding hematologic malignancy, germ cell tumor, small cell lung cancer. * Stable extracranial tumor (primary tumor and/or systemic metastases) during the last three months with or without treatment or progressive extracranial tumor and/or systemic metastases for which effective treatment is available. * World Health Organization (WHO) performance score 0-2. * Ability to provide written informed consent. Exclusion Criteria: * Prior treatment for brain metastases (i.e. surgery, stereotactic radiotherapy or WBRT). * Distant brain metastases or radiological findings on MRI suspected for leptomeningeal tumor spread on the postoperative MRI. * Concurrent use of systemic therapy during local stereotactic radiotherapy
References
Publications (0)
Data not yet available