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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
No surgical resection of the target lesion, defined as ≥3 cm but ≤6 cm in size on MRI of the Brain with contrast
Life expectancy>3 months
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have not had surgery to remove a specific brain lesion that is between 3 and 6 centimeters in size.
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You are expected to live for more than 3 months.
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You can join the study if you have received previous treatment for other lesions with stereotactic radiosurgery (SRS).
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You have been diagnosed with a non-blood-related cancer, except for small cell lung cancer, within the past 5 years.
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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.
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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.

Find a Location

Who is running the clinical trial?

Albert Einstein College of MedicineLead Sponsor
285 Previous Clinical Trials
11,856,611 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

Fractionated Stereotactic Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03726359 — Phase 1
Brain Tumor Research Study Groups: Fractionated Stereotactic Radiation Therapy
Brain Tumor Clinical Trial 2023: Fractionated Stereotactic Radiation Therapy Highlights & Side Effects. Trial Name: NCT03726359 — Phase 1
Fractionated Stereotactic Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03726359 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Fractionated Stereotactic Radiation Therapy attained regulatory approval?

"Our internal assessment of Fractionated Stereotactic Radiation Therapy's safety is rated 1, as the current Phase 1 trial has yet to provide ample evidence for efficacy and security."

Answered by AI

Are there any remaining opportunities for participants to join this research?

"This research study, which was initially listed on December 25th 2017, is still seeking participants. The clinicaltrials.gov entry has been recently refreshed on May 4th 2022."

Answered by AI

How many individuals are receiving the benefits of this clinical investigation?

"Affirmative. According to clinicaltrials.gov, this medical experiment is actively recruiting patients who first posted the trial on December 25th 2017 and recently updated it in May 4th 2022. 43 individuals are needed between a single location for participation."

Answered by AI
~6 spots leftby Mar 2025