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Radiation Therapy

Radiosurgery for Brain Tumor

Phase 1 & 2
Recruiting
Led By Erin Murphy, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies
Magnetic resonance imaging (MRI) evidence of 1-4 brain metastases, with at least one lesion > 20 mm and ≤ 50 mm in maximal diameter and determined to be appropriate for SRS and gross total resection; all other brain metastases are appropriate for SRS
Must not have
Inability to participate in study activities due to physical or mental limitations
Inability or unwillingness to return for all the required follow-up visits
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will study if radiosurgery followed by surgery can stop brain metastases from recurring, and evaluate any side effects.

Who is the study for?
This trial is for patients with certain types of cancer that have spread to the brain, specifically those with 1-4 brain metastases where at least one lesion is sizable but operable. Participants must be physically able to undergo surgery and radiosurgery, have a good performance status (Karnofsky score ≥ 70), and not have specific cancers like small cell lung cancer or lymphoma.
What is being tested?
The study tests if using radiosurgery before surgical removal of brain tumors can prevent them from returning. It aims to find the safest dose of focused x-ray radiation (radiosurgery) that causes minimal damage to healthy brain tissue while being effective against tumors.
What are the potential side effects?
Potential side effects may include typical reactions related to radiation such as headaches, nausea, fatigue, hair loss at treatment site, swelling in the brain around the tumor area, and possible short-term memory issues or other cognitive changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is not small cell lung cancer, lymphoma, or germ cell cancer.
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I have 1-4 brain tumors suitable for specific radiation and surgery, with one larger than 20mm but not over 50mm.
Select...
I am mostly able to care for myself and carry out normal activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot join in study activities because of my health or mental condition.
Select...
I cannot or do not want to come back for all required follow-up visits.
Select...
My treatment plan cannot limit radiation to 10 Gy or less to my optic nerve/chiasm.
Select...
My tumor is located in the brainstem.
Select...
I am considered medically unfit for surgery to remove brain cancer.
Select...
I have had whole brain radiotherapy before.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum tolerated dose (MTD)
Proportion of participants without local failure (Phase II)
Secondary study objectives
Proportion of participants with distant brain failure
Rate of radiation necrosis/steroid dependency
Rate of salvage treatment

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (radiosurgery, surgery)Experimental Treatment3 Interventions
Patients undergo radiosurgery on day 0. Within 2 weeks, patients undergo surgical resection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
radiosurgery
2009
N/A
~70
therapeutic conventional surgery
2003
Completed Phase 3
~12900
quality-of-life assessment
2012
Completed Phase 3
~2780

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
468 Previous Clinical Trials
33,400 Total Patients Enrolled
Erin Murphy, MDPrincipal InvestigatorCase Comprehensive Cancer Center
2 Previous Clinical Trials
500 Total Patients Enrolled

Media Library

Radiosurgery (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01891318 — Phase 1 & 2
Brain metastases Research Study Groups: Treatment (radiosurgery, surgery)
Brain metastases Clinical Trial 2023: Radiosurgery Highlights & Side Effects. Trial Name: NCT01891318 — Phase 1 & 2
Radiosurgery (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01891318 — Phase 1 & 2
~0 spots leftby Dec 2024
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