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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My cancer is not small cell lung cancer, lymphoma, or germ cell cancer.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
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)
Proportion of participants without local failure (Phase II)
Secondary outcome measures
Proportion of participants with distant brain failure
Rate of radiation necrosis/steroid dependency
Rate of salvage 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
~12270
quality-of-life assessment
2012
Completed Phase 3
~2780
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,874 Total Patients Enrolled
Erin Murphy, MDPrincipal InvestigatorCase Comprehensive Cancer Center
2 Previous Clinical Trials
500 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot join in study activities because of my health or mental condition.I cannot or do not want to come back for all required follow-up visits.My treatment plan cannot limit radiation to 10 Gy or less to my optic nerve/chiasm.I am mostly able to care for myself and carry out normal activities.My tumor is located in the brainstem.I am considered medically unfit for surgery to remove brain cancer.I have had whole brain radiotherapy before.I have had targeted radiation for other tumors, not the one planned for surgery.My cancer is not small cell lung cancer, lymphoma, or germ cell cancer.I have 1-4 brain tumors suitable for specific radiation and surgery, with one larger than 20mm but not over 50mm.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (radiosurgery, surgery)
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 vacancies for individuals who wish to participate in this research?
"Clinicialtrials.gov affirms that this medical trial is currently enrolling individuals. The experiment was initially posted on the 3rd of July 2013 and its information was most recently refreshed on August 15th 2022."
Answered by AI
What is the estimated total number of participants for this investigation?
"Affirmative, clinicaltrials.gov data indicates that enrolment into this medical research is currently underway. It was initially posted on July 3rd 2013 and most recently updated on August 15th 2022; the study requires 36 participants from a single site."
Answered by AI
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