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Radiation Therapy
Stereotactic Radiosurgery for Brain Metastasis
Phase 3
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Resection cavity must measure < 5.0 cm in maximal extent and the resection must be complete on the post-operative MRI obtained =< 30 days prior to pre-registration
Must be fluent in English, Spanish, or French
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is comparing two different types of radiation therapy to see which is more effective in treating cancer that has spread to the brain.
Who is the study for?
This trial is for patients with up to three brain metastases from cancer that has spread, but not from germ cell tumors, small cell carcinoma, or lymphoma. Participants must have had one tumor surgically removed within the last 30 days and can't have had whole brain radiation before. They should be able to complete questionnaires in English, Spanish, or French and undergo MRI scans.Check my eligibility
What is being tested?
The study compares single-dose stereotactic radiosurgery (a high dose of targeted radiation) with fractionated stereotactic radiosurgery (smaller doses over time) for treating resected brain metastasis. It aims to determine which method is more effective and less harmful to healthy tissue.See study design
What are the potential side effects?
Potential side effects may include headaches, nausea, fatigue, hair loss at the treatment site, swelling in the brain around the treated area (edema), hearing changes if near auditory structures; rarely seizures or neurological deficits depending on location.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My surgery area is smaller than 5.0 cm and fully removed, confirmed by a recent MRI.
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I am fluent in English, Spanish, or French.
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My cancer has spread to the protective covering of the brain.
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My cancer has not spread to the lining of my brain and spinal cord.
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My brain tumor originated from another part of my body.
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I can care for myself but cannot do normal activities or work.
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I have up to 3 brain tumors that haven't been surgically removed.
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My untreated cancer spots are smaller than 4.0 cm on my latest brain MRI.
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My brain tumor was larger than 2 cm before surgery.
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My brain cancer is not near the optic nerve or brainstem.
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I have never had whole brain radiation therapy.
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My cancer is not a germ cell tumor, small cell carcinoma, or lymphoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Surgical bed recurrence-free survival (SB-RFS)
Secondary outcome measures
Barthel Activities of Daily Living (ADL) Index
Barthel Activities of Daily Living (ADL) Index for long-term survivors
Brain
+11 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (FSRS)Experimental Treatment3 Interventions
Patients undergo FSRS over 3 or 5 daily sessions.
Group II: Arm I (SSRS)Active Control3 Interventions
Patients undergo SSRS over 1 session.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quality-of-Life Assessment
2017
Completed Phase 3
~4950
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,911 Total Patients Enrolled
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,396 Total Patients Enrolled
Paul D. Brown, MDStudy ChairMayo Clinic
3 Previous Clinical Trials
961 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer may have spread to my brain from another part of my body.My surgery area is smaller than 5.0 cm and fully removed, confirmed by a recent MRI.I am fluent in English, Spanish, or French.I had surgery to remove a brain tumor less than 30 days ago.My cancer has spread to the protective covering of the brain.My cancer has not spread to the lining of my brain and spinal cord.I am willing to use birth control during and up to 3 months after the study.I have not had surgery to remove more than one brain tumor.My brain tumor originated from another part of my body.I can care for myself but cannot do normal activities or work.I have taken a pregnancy test within the last week and it was negative.I have up to 3 brain tumors that haven't been surgically removed.My untreated cancer spots are smaller than 4.0 cm on my latest brain MRI.My brain tumor was larger than 2 cm before surgery.I had surgery to remove a brain tumor less than 30 days ago.My brain tumor originated from outside the brain.My brain cancer is not near the optic nerve or brainstem.I have had radiosurgery for other cancer lesions before.I have never had whole brain radiation therapy.My cancer is not a germ cell tumor, small cell carcinoma, or lymphoma.My brain metastasis size does not limit my eligibility.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (FSRS)
- Group 2: Arm I (SSRS)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Are participants still being accepted into this clinical trial?
"Yes, that is accurate. The clinical trial is currently recruiting patients, as indicated by the data on clinicaltrials.gov. The study was posted on October 11th, 2019, and was updated on April 18th, 2020. They are looking for 208 patients at 100 sites."
Answered by AI
How many medical participants are in this trial?
"208 individuals that fit the bill are needed to enroll in this study. Those interested can participate from various locations, such as Legacy Good Samaritan Hospital and Medical Center in Portland, Oregon and Fox Chase Cancer Center in Philadelphia, Pennsylvania."
Answered by AI
What are the risks associated with Fractionated Stereotactic Radiosurgery?
"Fractionated Stereotactic Radiosurgery has received a safety score of 3. This is because Phase 3 trials, of which this is one, have multiple rounds of data supporting safety as well as some data supporting efficacy."
Answered by AI
Across how many different facilities is this clinical trial being conducted?
"Currently, this clinical study is being conducted in 100 hospitals, with locations in Portland, Philadelphia, Houston and many other cities. If you enroll in the program, it is best to choose the site that is closest to you to avoid having to travel long distances."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
District of Columbia
New York
How old are they?
18 - 65
What site did they apply to?
McLaren Cancer Institute-Northern Michigan
What portion of applicants met pre-screening criteria?
Did not meet criteria
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