Clinical trial · Interventional
Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis
Phase I Dose Escalation Trial of Hypofractionated Radiosurgery for Large Brain Metastasis
NCT01705548CI-TRIAL-00110791completedN/AResults postedClinicalTrials.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 trial studies the side effects and best dose of hypofractionated radiosurgery in treating patients with large brain metastasis. Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Giving fractionated stereotactic radiosurgery may kill more tumor cells.
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 Malignant Neoplasm to Brain | Brain Neoplasm | PROBABILISTIC | 0.70 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated Radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypofractionated Radiosurgery
- description
- HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm. Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
- interventionNames
- Radiation: Hypofractionated Radiosurgery
Primary outcomes (2)
- measure
- Maximum Tolerated Dose (MTD) of Hypofractionated Radiosurgery Defined as the Highest Dose Level Where a Grade 3 or Greater With an Attribution Score of ≥ 3 Develops in ≤ 2 of 6 Patients in a Dose Group
- timeFrame
- 4 months
- description
- Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. The rate of toxicities will be calculated with 95% confidence interval (CI).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologic proven diagnosis of solid tumor malignancy * One brain metastasis or brain metastasis resection cavity with maximal diameter ≥ 3 cm (or ≥ 14 cc.) and ≤ 6 cm (or ≤ 113 cc.) * Recursive partitioning analysis (RPA) class I-II/ Karnofsky Performance status (KPS) ≥ 70% Exclusion Criteria: * Prior stereotactic radiosurgery (SRS) to adjacent lesion such that planning target volume would have received more than 12 Gy * RPA class III (KPS \< 70%) * Brain metastasis or resection cavity volume \< 3 cm or \> 6 cm * Radiosensitive or non-solid (eg. small cell lung carcinomas, germ cell tumors, leukemias, or lymphomas) or unknown tumor histologies * Concurrent chemotherapy (no chemotherapy starting 14 days before start of radiation) * Evidence of leptomeningeal disease by magnetic resonance imaging (MRI) and/or cerebrospinal fluid (CSF) cytology * Current pregnancy * More than 8 weeks between resection and radiosurgical procedure * Metastases to brain stem, midbrain, pons, or medulla or within 5 mm of the optic apparatus (optic nerves and chiasm) * Inability to undergo MRI evaluation for treatment planning and follow-up
References
Publications (0)
Data not yet available
No reference posted for this study.