Clinical trial · Interventional
Frameless Fractionated Stereotactic Radiation in Treating Patients With Brain Metastases
A Phase II Study of the Efficacy, Safety, and Cost of Frameless Fractionated Stereotactic Radiation for Parenchymal Brain Metastases
NCT02798029CI-TRIAL-00076380completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Malignant Neoplasm in the Brain | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Frameless Fractionated Stereotactic Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (FFSRT)
- description
- Patients undergo FFSRT daily over 30 minutes for 3-5 days.
- interventionNames
- Radiation: Frameless Fractionated Stereotactic Radiation Therapy
Primary outcomes (5)
- measure
- Incidence of lesion failure based on imagining assessments for each lesion
- timeFrame
- Up to 1 year
- measure
- Rates of local control
- timeFrame
- Up to 1 year
- measure
- Intracranial progression free survival (PFS)
- timeFrame
- From enrollment to either the first observation of progression disease in the brain or death due to any cause, assessed up to 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.