Your session is about to expire
← Back to Search
Reduced Dose Radiosurgery for Brain Metastases (RADREMI Trial)
N/A
Waitlist Available
Led By Gordon Watson, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Brain MRI-confirmed 1-10 solid tumor brain metastases
≥ 18 years old at the time of informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, 12 months post srs
Awards & highlights
RADREMI Trial Summary
This trial will look at how often radiation necrosis (tissue death from radiation) occurs in people with metastatic brain cancer who are first treated with immunotherapy and then with radiation therapy.
Who is the study for?
This trial is for adults with 1-10 confirmed brain metastases from solid tumors, expected to live at least 6 months. They must be suitable for stereotactic radiosurgery and can consent themselves. People with severe illnesses, more than 10 brain metastases, large lesions, or extensive disease volume; those who had certain prior treatments; or have autoimmune diseases cannot join.Check my eligibility
What is being tested?
The study tests if a lower dose of stereotactic radiosurgery (SRS), combined with standard immunotherapy, reduces the risk of radiation necrosis in patients with brain cancer that has spread. Participants will receive reduced-dose SRS after their regular immune checkpoint inhibitor treatment.See study design
What are the potential side effects?
Potential side effects include risks associated with radiation therapy such as headaches, nausea, hair loss at the treatment site, and fatigue. Immunotherapy may cause immune-related reactions affecting different organs.
RADREMI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have 1 to 10 confirmed brain tumors from cancer spread.
Select...
I am 18 years old or older.
Select...
My cancer was confirmed with a biopsy.
Select...
I am currently receiving chemotherapy.
RADREMI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months, 12 months post srs
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, 12 months post srs
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Gamma Knife local control rate
Gamma knife symptomatic radiation necrosis rate
Linear accelerator local control rate
+12 moreRADREMI Trial Design
1Treatment groups
Experimental Treatment
Group I: Reduced Dose Stereotactic RadiosurgeryExperimental Treatment1 Intervention
Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Reduced Dose SRS
2019
N/A
~30
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
983,050 Total Patients Enrolled
Gordon Watson, MDPrincipal InvestigatorIndiana University
Kevin Shiue, MDPrincipal InvestigatorIndiana University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had whole brain radiation therapy before.The doctor in charge of radiation treatment doesn't think you are a good fit for radiosurgery.I have 1 to 10 confirmed brain tumors from cancer spread.I have an autoimmune disease.My primary cancer site is unknown.My cancer type is not suitable for stereotactic radiosurgery, except if it's small cell lung cancer.Your absolute lymphocyte count is higher than 800 per microliter.I am 18 years old or older.I had a precise radiation treatment that overlaps with my current treatment area.My upcoming treatment will overlap by 20% or more with areas treated before.I had surgery for brain metastasis less than 30 days before starting ICI treatment.You have more than 10 brain tumors visible on a brain MRI.My radiation oncologist says I can have targeted radiation therapy.I have been on dexamethasone for more than 2 weeks before SRS.I have a tumor larger than 4 cm.Criterion: Your estimated survival time is at least 6 months, based on specific guidelines or the doctor's best assessment.My cancer was confirmed with a biopsy.My cancer spread is larger than 30 cubic centimeters.I received immune therapy within 30 days before starting radiation treatment.I am currently receiving chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Reduced Dose Stereotactic 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.
What is the maximum number of patients that can be enrolled in this clinical trial?
"That is correct, the online clinicaltrials.gov database has listings for this active trial which as of 8/29/2022 was last updated. The study originally began recruiting on 8/21/2019 and is looking for 42 individuals across 3 different medical facilities."
Answered by AI
Are there any available slots in this research project?
"The clinical trial is recruiting patients, as stated on the website clinicaltrials.gov. The original posting was on 8/21/2019, and it has been edited recently on 8/29/2022. They are looking for 42 participants who will be located at 3 different sites."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger