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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥18 years of age
Target lesion must be amenable to undergo surgical biopsy and LITT treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline through 24 months or study exit (whichever comes first)
Awards & highlights
Study Summary
This trial is studying two sets of treatment algorithms for brain metastases patients who have had stereotactic radiosurgery.
Who is the study for?
This trial is for adults over 18 who've had brain metastases treated with SRS at least 3 months ago. They must be stable on low-dose steroids, able to undergo biopsy and laser therapy, and commit to the study's follow-up. Women of childbearing age need a negative pregnancy test and agree to use contraception.Check my eligibility
What is being tested?
The REMASTer trial compares two treatment strategies after initial SRS for brain metastases: Radiation Therapy versus Laser Interstitial Thermal Therapy combined with Steroid Therapy. It's randomized, meaning patients are put into groups by chance.See study design
What are the potential side effects?
Potential side effects include those related to radiation (fatigue, hair loss, skin irritation), laser therapy (swelling, pain at the site), and steroid therapy (weight gain, mood changes). Each patient may experience side effects differently.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My cancer can be biopsied and treated with laser therapy.
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I've been stable for 3 days on a low steroid dose.
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I am mostly able to take care of myself.
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My brain tumor is growing despite previous treatments.
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I am a woman and my pregnancy test was negative.
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I have brain metastases from a cancer that did not originate in the brain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment through 24 months or study exit (whichever comes first). measurements occur at baseline, post-op visit, 1 month visit, and each subsequent follow up visit until study exit or at 24 months, whichever comes first.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment through 24 months or study exit (whichever comes first). measurements occur at baseline, post-op visit, 1 month visit, and each subsequent follow up visit until study exit or at 24 months, whichever comes first.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progressive Disease Cohort
Radiation Necrosis Cohort
Secondary outcome measures
Progressive Disease Cohort: Overall Survival
Radiation Necrosis Cohort: Freedom from Local Progression (FFLP) or Neurological Death
Other outcome measures
Cognitive Measure- HVLT
Cognitive Measure- Trail Making Test
Describe Quality of Life (QoL) and cognition over time
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Recurrent TumorExperimental Treatment2 Interventions
Receives Laser Interstitial Thermal Therapy (LITT) followed by surveillance or Receives Laser Interstitial Thermal Therapy (LITT) followed by hypofractionated radiation therapy (RT).
Group II: Radiation NecrosisExperimental Treatment2 Interventions
Receives Laser Interstitial Thermal Therapy (LITT) and best medical management with steroids or Receives best medical management with steroids.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Laser Interstitial Thermal Therapy
2014
N/A
~10
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Who is running the clinical trial?
Monteris MedicalLead Sponsor
9 Previous Clinical Trials
1,359 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I've been stable for 3 days on a low steroid dose.My cancer outside the brain is quickly getting worse.I do not have any serious infections or other major health issues.I had my initial SRS treatment for the target lesion over 3 months ago.I am mostly able to take care of myself.My brain tumor is growing despite previous treatments.My cancer can be biopsied and treated with laser therapy.I cannot have surgery due to my health condition.I am a woman and my pregnancy test was negative.I have cancer that has spread to the lining of my brain and spinal cord.I have not used bevacizumab in the last 4 weeks.I cannot undergo or am not eligible for stereotactic radiosurgery.I am receiving treatment for another cancer besides the one being studied.I have brain metastases from a cancer that did not originate in the brain.I have more than 3 tumors that are getting worse.I have recently been diagnosed with brain metastases.My blood counts are within a healthy range.I am willing and able to follow the study's requirements.I cannot take steroids due to health reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Recurrent Tumor
- Group 2: Radiation Necrosis
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.
Are there any openings left in this medical research study?
"The clinical trial is currently enrolling patients, and information available on the website indicates that it was initially posted in May of 2022 with a recent update occurring June 23rd."
Answered by AI
What is the current recruitment quota for this trial?
"Indeed, the clinicaltrials.gov website reveals that this medical research is actively enrolling patients. This trial was initially posted on May 10th 2022 and most recently updated on June 23rd of the same year; aiming to recruit 154 individuals from two distinct sites."
Answered by AI
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