Clinical trial · Interventional
Stereotactic Radiosurgery After Surgery in Treating Patients With Brain Metastases
Phase II Single-arm Study of Post-operative Stereotactic Radiosurgery for Brain Metastases.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Early analysis indicated SRS not as beneficial post-op as pre-op
Summary
Brief summary (as posted)
RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating patients with brain metastases.
Conditions
Conditions (2)
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 Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MMSE | Behavioral | — | UNRESOLVED |
| MRI | Procedure | — | UNRESOLVED |
| Post-operative SRS | Radiation | — | UNRESOLVED |
| QOL via FACT-Br | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- ACTIVE_COMPARATOR
- label
- Post-operative SRS
- description
- All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.
- interventionNames
- Behavioral: MMSE
- Behavioral: QOL via FACT-Br
- Procedure: MRI
- Radiation: Post-operative SRS
Primary outcomes (1)
- measure
- Recurrence Rate at the Surgical Site as Measured by MRI
- timeFrame
- 12 months
- description
- The number of months for local recurrence via MRI
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \>18 years of age. 2. Gross total resection (as verified by the lack of any enhancement in the resection cavity on post-operative MRI) of single brain metastasis confirmed by histology. Patients with up to 4 metastases are eligible if the largest mass is amenable to surgical resection and all non-resected masses are amenable to SRS. 3. Patient must be Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis (RPA) Class 1 or 2. 4. Life expectancy of at least 3 months. Exclusion Criteria: 1. Radiographic or cytologic evidence of leptomeningeal disease. 2. Patient with incomplete or partial resection. 3. Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma). 4. Patients with a resection cavity \> 4 cm in maximal extent in any plane on contrasted MRI scan. 5. Lesion located in anatomic regions which are not amenable to SRS including the brain stem and optic apparatus. 6. Pregnant or need to breast feed during the study period. 7. Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness. 8. Brain surgery other than for resection of metastasis. 9. Previous brain radiotherapy. 10. Contraindication to SRS, WBRT, or MRI.
References
Publications (0)
Data not yet available