Stereotactic Radiosurgery in Treating Patients With Large Brain Metastases (NCT01843413) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Stereotactic Radiosurgery in Treating Patients With Large Brain Metastases
United States33 participantsStarted 2013-07-02
Plain-language summary
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.
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:
* 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
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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 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
2
Response associated with increased dose of SRS as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II)