Frameless Fractionated Stereotactic Radiation in Treating Patients With Brain Metastases
Completed · Phase 2
Conditions studied: Metastatic Malignant Neoplasm in the Brain
In brief
This phase II trial studies the safety and efficacy of frameless fractionated stereotactic radiation therapy for brain metastases. Frameless fractionated stereotactic radiosurgery is a specialized radiation therapy that delivers 3 to 5, high dose fractions of radiation directly to the brain lesions while sparing normal tissues.
Key facts
- Study ID
- NCT02798029
- Run by
- M.D. Anderson Cancer Center
- People needed
- 35
- Starts
- 2016-08-08
- Expected to finish
- 2024-04-19
- Last updated by the study team
- 2024-04-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All patients with 1-4 metastatic brain lesions who are considered eligible for single-fraction, frame-based SRS, who are unable or unwilling to undergo frame-based SRS
- One to 4 untreated metastatic brain lesions
- Each brain lesion must be less than or equal to 5 cm in diameter and not an optimal surgical candidate
- Patient must be able have a magnetic resonance imaging (MRI) of the brain for treatment planning
- Histologic confirmation of malignancy
- For patients of childbearing potential, non-pregnant state, confirmed by negative serum or urine beta-human chorionic gonadotropin (HCG) within (7) days of planned radiation treatment
- Glomerular filtration rate (GFR) adequate for intravenous (IV) contrast delivery for imaging
- No concurrent chemotherapy
- Patient may have had prior therapy for brain metastasis, including radiosurgery and surgical resection at the discretion of the treating physician however only new untreated lesions will be followed on protocol.
You may not qualify if…
- Five or more metastatic brain lesions
- Brain lesion(s) greater than 5 cm in diameter
- Lesion(s) involving the brainstem, optic chiasm or optic nerve(s)
- Patients unable to have IV contrast for computed tomography (CT) and MRI imaging
- Patient unable to have an MRI of the brain
- Patients willing to be treated with frame-based gamma knife SRS at MD Anderson main campus or MD Anderson at the Woodlands
- Positive pregnant status confirmed by serum or urine pregnancy test
- Primary small cell lung cancer, myeloma, lymphoma, leukemia, or other histologies not optimally treated with SRS
- Patients currently receiving chemotherapy/biologic/immunotherapy as these need to be held during FFSRT
- Prior whole brain radiotherapy or conventional external beam radiotherapy
Where it is running
- Presbyterian Hospital — Albuquerque, New Mexico, United States
- MD Anderson in The Woodlands — Conroe, Texas, United States
- M D Anderson Cancer Center — Houston, Texas, United States
- MD Anderson West Houston — Houston, Texas, United States
Full record on ClinicalTrials.gov
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