N/A
N=24
Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis
Metastatic Malignant Neoplasm to Brain · Unspecified Adult Solid Tumor, Protocol Specific
Bottom Line
View on ClinicalTrials.gov: NCT01705548 ↗Enrolled (actual)
24
Serious AEs
12.5%
Results posted
May 2026
Primary outcome: Primary: 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 — 6.5 Gy x 5 fractions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hypofractionated Radiosurgery (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
6.5 | — |
| PRIMARY Percentage of Participants With Neurologic Toxicity/Radiation Necrosis Possibly Due to Treatment, Graded According to the CTCAE Version 4.03 as Grade 2 or Greater. |
0; 17; 44 | — |
| SECONDARY Local Control; Lack of Progression of Disease in Resection Cavity as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria |
6 | — |
| SECONDARY Intercranial Progression Free Survival: Lack of Progression of Disease in Surrounding Brain as Defined by RECIST Criteria |
46 | — |
| SECONDARY Freedom From Failure/Progression Free Survival |
7 | — |
| SECONDARY Overall Survival (OS): Death From Any Cause |
9 | — |
| SECONDARY Change in Hopkins Verbal Learning Test-Revised (HVLT-R) Scores |
20 | — |
| SECONDARY Quality of Life (QOL) Outcomes: Using the Quality of Life Questionnaire for the Functional Assessment of Cancer Therapy-Brain (FACT-Br). |
4; 11 | — |
Summary
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT01705548). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.