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Radiation Therapy
Fractionated Stereotactic Radiation Therapy for Brain Cancer
Phase 1
Recruiting
Led By Madhur Garg, MD
Research Sponsored by Albert Einstein College of Medicine
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 1 year
Awards & highlights
Study Summary
This trial is testing a new way to give radiation for brain cancer. They want to see if it is safe and what the best dose is.
Who is the study for?
This trial is for adults with brain metastases larger than 3 cm but smaller than 6 cm, who haven't had surgery on the lesion. They can have had whole brain radiation before and may have other lesions treated separately. Participants need to be relatively active (Karnofsky ≥60 or ECOG ≤2), not pregnant, and expected to live more than 3 months.Check my eligibility
What is being tested?
The study tests Fractionated Stereotactic Radiation Therapy (FSRT) to find the highest dose patients can tolerate without severe side effects. This Phase I trial will set the stage for future studies by establishing safe dosage levels of FSRT in treating brain metastases.See study design
What are the potential side effects?
While specific side effects are not listed here, FSRT could potentially cause headaches, fatigue, hair loss at treatment site, skin irritation like sunburn, nausea, and swelling due to inflammation around the treated area.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Fractionated Stereotactic Radiation TherapyExperimental Treatment1 Intervention
This study is unique in that it employs a continuous reassessment methodology (CRM) to determine the Maximum Tolerated Dose. Information for the proper dose level for each subsequent patient enrolled will be determined based on DLTs from previous patients enrolled in the trial.
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Who is running the clinical trial?
Albert Einstein College of MedicineLead Sponsor
287 Previous Clinical Trials
11,857,165 Total Patients Enrolled
Madhur Garg, MD5.01 ReviewsPrincipal Investigator - Montefiore
Albert Einstein College of Medicine
3 Previous Clinical Trials
65 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to perform daily activities without much difficulty.You can have more than one tumor, but only the main tumor will be treated for this study. Any other tumors may also be treated, but won't be part of the study's main goals.You have brain tumors caused by certain types of cancer.You are expected to live for more than 3 months.You cannot have metal implants that are not safe for MRI scans. If you have MRI-safe implants, you can still participate.You have brain metastases that have been confirmed with a recent MRI using contrast dye. If your diagnosis was done with a CT scan instead of an MRI, you can't participate.You have a serious health condition that is not being managed well, like heart problems or seizures.You have not had surgery to remove a specific brain lesion that is between 3 and 6 centimeters in size.You can join the study if you have received previous treatment for other lesions with stereotactic radiosurgery (SRS).You have received radiation therapy for the specific areas of concern in the past.You have been diagnosed with leptomeningeal metastases based on a cerebrospinal fluid examination.You are planning to receive chemotherapy or targeted therapy during the study. However, you can continue any hormonal therapy or bone support therapy you are currently receiving.You have been diagnosed with a non-blood-related cancer, except for small cell lung cancer, within the past 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Fractionated Stereotactic Radiation Therapy
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.
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