Clinical trial · Interventional
Stereotactic Radiosurgery Compared to Observation in Treating Patients With Brain Metastases
Efficacy of Post-Surgical Stereotactic Radiosurgery for Metastatic Brain Disease: A Randomized Trial
NCT00950001CI-TRIAL-00121482active not recruitingPhase 3ClinicalTrials.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 randomized phase III trial studies stereotactic radiosurgery to see how well it works compared to clinical observation after surgery in treating patients with brain metastases. Stereotactic radiosurgery, a type of radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
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 |
|---|---|---|---|
| Metastatic Malignant Neoplasm in the Brain | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (SRS)
- description
- Patients undergo stereotactic radiosurgery to the surgical cavity within 30 days of the craniotomy.
- interventionNames
- Radiation: Stereotactic Radiosurgery
- type
- NO_INTERVENTION
- label
- Arm II (observation)
- description
- Patients undergo clinical observation after craniotomy.
Primary outcomes (1)
- measure
- Time to local recurrence
- timeFrame
- 6 months
- description
- A univariate test between groups will be conducted using a log rank test of Kaplan-Meier survival estimates and multivariate analyses will be conducted via the Cox proportional hazards model. The hazard ratio comparing each arm will be computed for each endpoint with and without adjustment for other covariates. Confidence intervals (95%) will be computed for the hazard ratio estimates. The proportion of patients experiencing neurological complications will be computed via univariate and multivariate logistic regression analysis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must be older than 3 years of age (radiosurgical frames cannot be placed on children younger than age 3). 2. Patients must have 3 or fewer newly diagnosed metastatic lesions in the brain with a complete resection of at least one lesion as determined the study neuroradiologist. 3. The resection cavity must have a maximum diameter of less than or equal to 4cm. This criteria will be determined by the study radiologist. 4. Additional unresected brain metastases (up to 2) must have a maximum diameter of less than or equal to 3 cm. 5. Patients must be considered candidates for SRS within 30 days of surgical resection. 6. Patients must have a Karnofsky Performance Scores (KPS) of at least 70 at the first post operative visit. Patients under 18 years of age must have a Lansky Performance Score of of at least 70. 7. Patients must be able to undergo an MRI scan. 8. Patients must agree to randomization as documented by signing the Institutional Review Board (IRB) approved consent form. Exclusion Criteria: 1. Patients who have received prior radiation therapy to the brain for any reason. 2. There is radiographic evidence of leptomeningeal disease prior to study entry. 3. The primary tumor is small-cell lung cancer, lymphoma, leukemia, or multiple myeloma. 4. For females, if they are pregnant or breast-feeding (The exclusion is made because gadolinium may be teratogenic in pregnancy).
References
Publications (1)
- DERIVEDMahajan A, Ahmed S, McAleer MF, Weinberg JS, Li J, Brown P, Settle S, Prabhu SS, Lang FF, Levine N, McGovern S, Sulman E, McCutcheon IE, Azeem S, Cahill D, Tatsui C, Heimberger AB, Ferguson S, Ghia A, Demonte F, Raza S, Guha-Thakurta N, Yang J, Sawaya R, Hess KR, Rao G. Post-operative stereotactic radiosurgery versus observation for completely resected brain metastases: a single-centre, randomised, controlled, phase 3 trial. Lancet Oncol. 2017 Aug;18(8):1040-1048. doi: 10.1016/S1470-2045(17)30414-X. Epub 2017 Jul 4. PMID 28687375