CompletedNot Applicable

Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis

United States24 participantsStarted 2012-09-24

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

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.

Timeframe: Up to 2 years

Trial details

NCT IDNCT01705548

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-11

Results submitted2025-10-15

View on ClinicalTrials.gov More Metastatic Malignant Neoplasm to Brain trials