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Radiation Therapy
Stereotactic Radiation for Brain Metastasis
Phase 2
Waitlist Available
Led By Stephen Chun
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trialstudies a specialized radiation therapy to treat brain metastases while minimizing effects on healthy tissue.
Who is the study for?
This trial is for patients with 1-4 brain metastases, each less than 5 cm in diameter. They should have confirmed malignancy but not be optimal candidates for surgery or unwilling to undergo frame-based SRS. Participants must be able to have an MRI and not be pregnant, without current chemotherapy or a history of certain cancers like small cell lung cancer.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of frameless fractionated stereotactic radiation therapy on brain lesions. This non-invasive treatment targets high doses of radiation at the tumors over several sessions while minimizing damage to healthy tissue.See study design
What are the potential side effects?
Potential side effects may include headaches, fatigue, hair loss at the treatment site, nausea, skin irritation around the treated area, swelling or edema in the brain which might require medication management.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have 1 to 4 brain lesions that have not been treated.
Select...
My brain tumor is 5 cm or smaller and surgery isn't the best option for me.
Select...
I am not currently receiving chemotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cost data
Incidence of lesion failure based on imagining assessments for each lesion
Intracranial progression free survival (PFS)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (FFSRT)Experimental Treatment1 Intervention
Patients undergo FFSRT daily over 30 minutes for 3-5 days.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,632 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,767 Total Patients Enrolled
Stephen ChunPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot have IV contrast for CT or MRI scans.You cannot have a brain MRI.You are confirmed to be pregnant with a positive pregnancy test.I have five or more cancer spots in my brain.I have a brain tumor larger than 5 cm.My cancer type is not best treated with stereotactic radiosurgery.I have 1-4 brain tumors but can't or won't have a specific type of radiation therapy.My kidneys are healthy enough for IV contrast.My cancer affects the brainstem, optic chiasm, or optic nerves.I am not currently on chemotherapy, biologic, or immunotherapy treatments.I am willing to undergo gamma knife surgery at MD Anderson or its Woodlands campus.I have had whole brain radiotherapy or external beam radiotherapy before.If you could become pregnant, a test has confirmed that you are not currently pregnant.Your doctor has confirmed that you have cancer through a tissue sample.I have 1 to 4 brain lesions that have not been treated.My brain tumor is 5 cm or smaller and surgery isn't the best option for me.I may have had treatment for brain cancer spread, but only new, untreated spots will be monitored.I am not currently receiving chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (FFSRT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is registration still open for this medical experiment?
"According to information hosted on clinicaltrials.gov, the recruitment period for this trial has concluded as of October 12th 2022. While it is not currently seeking participants, 2687 other medical studies are actively recruiting patients at present."
Answered by AI
Has the FDA granted approval for Frameless Fractionated Stereotactic Radiation Therapy?
"Our team at Power rated the safety of Frameless Fractionated Stereotactic Radiation Therapy as a 2 based on evidence available from Phase 2 trials, which demonstrate sufficient safety but lack efficacy data."
Answered by AI
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