Clinical trial · Interventional
Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
NCT01891318CI-TRIAL-00120951recruitingPhase 1 / Phase 2ClinicalTrials.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 Phase I/II trial studies the ability to stop brain metastases from coming back after treatment with radiosurgery followed by surgical resection. It will also evaluate the side effects of these combined treatments and help determine the best radiosurgery dose. Radiosurgery focuses the x-rays directly to the tumor and cause less damage to the normal tissue in the brain.
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 |
|---|---|---|---|
| Tumors Metastatic to Brain | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| radiosurgery | Radiation | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (radiosurgery, surgery)
- description
- Patients undergo radiosurgery on day 0. Within 2 weeks, patients undergo surgical resection.
- interventionNames
- Radiation: radiosurgery
- Procedure: therapeutic conventional surgery
- Procedure: quality-of-life assessment
Primary outcomes (2)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- Day 0
- description
- MTD of radiosurgery determined by dose-limiting toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 (Phase I)
- measure
- Proportion of participants without local failure (Phase II)
- timeFrame
- Up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have a prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies * Magnetic resonance imaging (MRI) evidence of 1-4 brain metastases, with at least one lesion \> 20 mm and ≤ 50 mm in maximal diameter and determined to be appropriate for SRS and gross total resection; all other brain metastases are appropriate for SRS * Patient can have prior SRS to lesions other than the one planned for neoadjuvant SRS and resection * Patient must have a Karnofsky performance score of ≥ 70 Exclusion Criteria: * Patient deemed medically unfit to undergo surgical resection of brain metastasis * Prior whole brain radiotherapy * Patient with contraindication for imaging with MRI * Inability to participate in study activities due to physical or mental limitations * Inability or unwillingness to return for all the required follow-up visits * At the time of planning, unable to deliver 10 Gray (Gy) or less to optic nerve/chiasm * Tumor located in the brainstem * Imaging or cytologic evidence of leptomeningeal disease
References
Publications (0)
Data not yet available
No reference posted for this study.