Clinical trial · Interventional
Stereotactic Radiosurgery in Treating Patients With Brain Metastases
Phase II Single-arm Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases.
NCT00811655CI-TRIAL-00012724terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow recruitment
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 before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| stereotactic radiosurgery | Radiation | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pre-Operative SRS
- description
- SRS pre-operatively with the planned target volume defined as the tumor plus a 3-mm margin.
- interventionNames
- Procedure: therapeutic conventional surgery
- Radiation: stereotactic radiosurgery
Primary outcomes (1)
- measure
- Number of Patients With Local Recurrence at the Surgical Site Within 12 Months After Stereotactic Radiosurgery (SRS)
- timeFrame
- Within 12 months after SRS
- description
- Number of patients with local recurrence at the surgical site within 12 months after stereotactic radiosurgery (SRS) as measured by magnetic resonance imaging (MRI). To determine local recurrence, we evaluated follow-up MRI's for reappearance of a lesion in exactly the same site in the brain as the first lesion(s).
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of brain metastases from an extracranial primary site * Tumor ≤ 4 cm in maximal extent in any plane on contrast MRI * Scheduled to undergo gross total resection of a single brain metastasis confirmed by histology * Up to 4 metastases allowed provided the largest mass is amenable to surgical resection and all non-resected masses are amenable to stereotactic radiosurgery (SRS) * RTOG Recursive Partitioning Analysis (RPA) class 1 or 2, as defined by the following: * RPA class 1: Karnofsky performance status (KPS) 70-100%; age \< 65 years; controlled primary disease; and no extracranial metastatic disease * RPA class 2: KPS 70-100%; uncontrolled primary disease; and/or extracranial metastatic disease * No lesion located in anatomic regions that are not amenable to SRS, including the brain stem, optic apparatus, or eloquent cortex * No primary lesion with radiosensitive histology (e.g., small cell carcinoma, germ cell tumors, lymphoma, leukemia, or multiple myeloma) * No radiographic or cytologic evidence of leptomeningeal disease PATIENT CHARACTERISTICS: * See Disease Characteristics * Not pregnant or nursing * Negative pregnancy test * No concurrent uncontrolled illness including, but not limited to, any of the following: * Symptomatic congestive heart failure * Unstable angina pectoris * Psychiatric illness * No contraindication to SRS, whole-brain radiotherapy, or MRI PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior brain surgery other than resection of metastasis * No prior brain radiotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.