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
2 other identifiers
interventional
35
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2016
Longer than P75 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2016
CompletedFirst Posted
Study publicly available on registry
June 14, 2016
CompletedStudy Start
First participant enrolled
August 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2024
CompletedApril 23, 2024
April 1, 2024
7.7 years
June 9, 2016
April 22, 2024
Conditions
Outcome Measures
Primary Outcomes (5)
Incidence of lesion failure based on imagining assessments for each lesion
Up to 1 year
Rates of local control
Up to 1 year
Intracranial progression free survival (PFS)
Will be summarized using the Kaplan-Meier method and the 50th percentile of the Kaplan-Meier distribution will determine the median intracranial PFS.
From enrollment to either the first observation of progression disease in the brain or death due to any cause, assessed up to 1 year
Overall survival (OS)
Will be summarized using the Kaplan-Meier method and the 50th percentile of the Kaplan-Meier distribution will determine the median intracranial OS.
Up to 1 year
Cost data
Will be summarized using descriptive statistics such as mean, median, standard deviation, and range. Comparisons in cost between treatment modalities will be evaluated using a paired t-test where each patient will serve as his or her own control to determine if the cost of frameless fractionated stereotactic radiation therapy (FFSRT) is comparable to standard treatment.
Up to 1 year
Study Arms (1)
Treatment (FFSRT)
EXPERIMENTALPatients undergo FFSRT daily over 30 minutes for 3-5 days.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (4)
Presbyterian Hospital
Albuquerque, New Mexico, 87106, United States
MD Anderson in The Woodlands
Conroe, Texas, 77384, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
MD Anderson West Houston
Houston, Texas, 77079, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Chun
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2016
First Posted
June 14, 2016
Study Start
August 8, 2016
Primary Completion
April 19, 2024
Study Completion
April 19, 2024
Last Updated
April 23, 2024
Record last verified: 2024-04