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Radiation Therapy
Hypofractionated Radiosurgery for Brain Metastasis
N/A
Waitlist Available
Led By Bree Eaton, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial looks at the side effects and best dose of a type of radiation therapy called stereotactic radiosurgery in treating patients with large brain metastasis.
Who is the study for?
This trial is for patients with a single large brain metastasis from solid tumors, measuring between 3 and 6 cm. Participants must have good performance status (able to carry out daily activities) and no more than one prior brain surgery. Excluded are those with very poor health, recent chemotherapy, certain tumor types like leukemia or lymphoma, pregnancy, or metastases in critical brain areas.Check my eligibility
What is being tested?
The study is testing the safety and optimal dosage of hypofractionated stereotactic radiosurgery—a type of targeted radiation therapy—for treating large brain tumors. The goal is to destroy tumor cells while sparing healthy tissue.See study design
What are the potential side effects?
Potential side effects may include headaches, nausea, fatigue, hair loss at treatment site, swelling in the brain which can cause neurological symptoms depending on location such as weakness or speech difficulties.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) of hypofractionated radiosurgery defined as the highest dose level where a grade 3 or greater with an attribution score of ≥ 3 develops in ≤ 2 of 6 patients in a dose group
Neurologic toxicity due to treatment, graded according to the CTCAE version 4.03
Secondary outcome measures
Distant control: lack of progression of disease in surrounding brain as defined by RECIST criteria
Freedom from failure/progression free survival
Local control; lack of progression of disease in resection cavity as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Hypofractionated RadiosurgeryExperimental Treatment1 Intervention
HR (Hypofractionated Radiosurgery) delivered in 5 fractions, with a minimum of 2 and a maximum of 3 fractions being delivered per week, to patients with brain metastases or resection cavity greater than 3 cm and less than 6 cm.
Dose escalation will proceed according to the Escalation with Overdose Control (EWOC) method with a planned total enrollment of 24 patients, in 8 patient cohorts with 3 patients per cohort. A 4 month observation period will occur for each completed cohort prior to dose escalation, with a goal timeline for trial completion of 4 years from first patient enrollment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiosurgery
2012
N/A
~110
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,548 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,563 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,128 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are unable to have an MRI scan for planning and follow-up of your treatment.You have a type of cancer that is sensitive to radiation or is not a solid tumor.You are not currently receiving chemotherapy, and you have not started chemotherapy within 14 days before starting radiation.You have signs of disease in the covering of the brain and spinal cord, as shown by MRI or fluid testing.You have a brain tumor that is bigger than 3 cm in diameter but smaller than 6 cm.You have significant difficulty carrying out daily activities and have a Karnofsky Performance Status score less than 70%.If you had surgery, it must have been more than 8 weeks before the radiosurgery.You have brain tumors that are either too small or too large for this study.Cancer has spread to certain parts of the brain or is very close to the optic nerves and chiasm.You have a confirmed diagnosis of a solid tumor cancer.You have had a specific type of radiation treatment to a nearby area and received a high dose.You have a good overall health and ability to perform daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: Hypofractionated Radiosurgery
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 there presently an opportunity for individuals to become participants in this trial?
"Clinicaltrials.gov reveals that this particular medical study is no longer seeking test subjects, notwithstanding its initial post date of September 24th 2012 and last edit on June 16th 2022. Fortunately, there are 3115 other trials currently enrolling patients at the present moment."
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