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Device
Tumor Treating Fields for Brain Cancer
N/A
Recruiting
Led By Jim Zhong, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky performance status >= 70%
Age >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from ttfields start to death from any cause, assessed up to 36 months
Awards & highlights
Study Summary
This trial is testing a new brain cancer treatment that uses low-intensity electric fields to interfere with cancer cell division.
Who is the study for?
Adults with brainstem gliomas who've finished cancer therapy at least 4 weeks prior, have a life expectancy over 12 weeks, and can follow the study plan. They need normal organ/marrow function and must use birth control. Excluded are those with uncontrolled illnesses, recent significant cardiovascular events, HIV on antiretroviral therapy, or recent investigational treatments.Check my eligibility
What is being tested?
The trial is testing the Optune device's safety and side effects for patients with brainstem gliomas. The device delivers low-intensity electric fields to disrupt cancer cell division in hopes of stopping tumor growth or shrinking it.See study design
What are the potential side effects?
Specific side effects of the Optune device aren't detailed here but may include skin irritation under the device pads, headaches, malaise or other discomfort related to wearing the device continuously.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself but may not be able to do active work.
Select...
I am 18 years old or older.
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My blood and organ functions are within the required ranges for treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from ttfields start to death from any cause, assessed up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from ttfields start to death from any cause, assessed up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Overall response rate
Overall survival (OS)
Progression free survival (PFS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (tumor treating fields)Experimental Treatment1 Intervention
After completion of standard of care radiation therapy, patients wear the Optune device for 18 hours per day for 12 months in the absence of disease progression or unacceptable toxicity.
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Who is running the clinical trial?
Emory UniversityLead Sponsor
1,639 Previous Clinical Trials
2,560,636 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,926,123 Total Patients Enrolled
Jim Zhong, MDPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to care for myself but may not be able to do active work.I am willing and able to follow the study's schedule and procedures.I finished my chemotherapy or radiotherapy more than 6 months ago.I am HIV-positive and not on antiretroviral therapy.I am 18 years old or older.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I haven't had major heart or blood vessel problems in the last 3 months.My brain tumor affects deep parts of my brain and diagnosis was confirmed without needing a biopsy.I finished all my cancer treatments, including surgery and radiotherapy, more than 4 weeks ago.My blood and organ functions are within the required ranges for treatment.I am not pregnant, can use birth control, and understand the need for it during and after the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (tumor treating fields)
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 available for prospective participants in this research endeavor?
"The data on clinicaltrials.gov declares that this trial is currently open for recruiting and has been since May 11th 2022, with the most recent update occuring one day later."
Answered by AI
How many participants are expected to be recruited for this clinical experiment?
"Affirmative. The clinical trial is still recruiting, and the data on clinicaltrials.gov indicates that it was posted on May 11th 2022 with a subsequent update made in 12 days' time. 10 patients are necessary to be sourced from 3 medical sites."
Answered by AI
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