Clinical trial · Interventional
Stereotactic Radiosurgery in Treating Patients With Large Brain Metastases
Dose Escalation for Larger Brain Metastases: Phase I/II Study
NCT01843413CI-TRIAL-00092399active not recruitingPhase 1ClinicalTrials.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 side effects and the best dose of stereotactic radiosurgery and to see how well it works in treating patients with large brain metastases. Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.
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 |
|---|---|---|---|
| Tumors Metastatic to Brain | Brain Neoplasm | PROBABILISTIC | 0.70 |
| Unspecified Adult Solid Tumor | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cognitive assessment | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| stereotactic radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (SRS)
- description
- Patients undergo SRS guided by CT and MRI.
- interventionNames
- Radiation: stereotactic radiosurgery
- Procedure: quality-of-life assessment
- Procedure: cognitive assessment
Primary outcomes (2)
- measure
- Maximum-tolerated dose based on the incidence of dose-limiting toxicity (DLT) defined as any grade III or IV toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
- timeFrame
- Up to 4 months
- measure
- Response associated with increased dose of SRS as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II)
- timeFrame
- Up to 2 years
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Any patient undergoing SRS for brain metastases * Lesions to be treated under this protocol must be \> 2 cm, but =\< 4.0 cm in diameter * Patients may have had prior therapy including: * Whole brain radiation therapy (WBRT) \> 3 months ago * SRS to other brain metastases * Patients with newly diagnosed brain metastases are eligible as long as they are not planned for WBRT upfront * Any primary is eligible with exception of small cell lung cancer, lymphoma, and germ cell histologies * Patient must be able to provide written informed consent Exclusion Criteria: * Patients receiving SRS to resection bed * Planned concurrent WBRT * Leptomeningeal metastases * Small cell lung cancer, lymphoma, and germ cell histologies * Inability to participate in study activities due to physical or mental limitations * Inability or unwillingness to return for all the required follow-up visits * Conformality index 2.0 or less cannot be achieved, or homogeneity index is \> 2.0 * Unable to deliver 10 Gray (Gy) or less to optic nerve/chiasm * Brainstem location is excluded from this study
References
Publications (0)
Data not yet available
No reference posted for this study.