Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis (NCT01705548) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was trying to find the maximum tolerated dose of hypofractionated radiosurgery for large brain metastases — since it has completed, what did it find about the safest effective dose, and would that approach apply to my situation?
2One of the main things this study measured was radiation necrosis and neurologic toxicity — how would my doctor watch for those side effects, and what are the warning signs I or my family should look out for?
3Since this trial focused specifically on 'large' brain metastases, how does the size of my tumor affect which radiation approach my doctor would recommend, and do I meet the kind of criteria this study was looking at?
4Because this was a dose-finding study rather than a comparison against standard treatment, how does my doctor weigh the evidence from a trial like this against more established radiation options like whole-brain radiation or standard single-session radiosurgery?
5Given that this trial is now completed, is my doctor aware of any published results, and are there follow-up studies or current trials building on this work that might also be worth discussing for my care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
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.