GliomaNCT05310448
Tumor Treating Fields for the Treatment of Brainstem Gliomas
A study testing Optune device in people with Glioma, run by Emory University at 3 sites in United States.
Trial summary
This clinical trial tests the safety and side effects of tumor treating fields in treating patients with gliomas located in the brainstem. Optune is a wearable, portable, treatment that creates low-intensity, wave-like electric fields called tumor treating fields (TTFields), which interfere with cancer cell division. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- Optune device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 May 2022to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years
- Karnofsky performance status >= 70%
- Life expectancy > 12 weeks as determined by the investigator
- Diagnosis of glioma with at least partial involvement or invasion of thalamus, cerebral peduncles, midbrain, pons, or medulla. Confirmation of diagnosis by biopsy or maximal safe resection preferred. If multi-disciplinary tumor board recommend no benefit and likely harm of attempting biopsy then can establish consensus clinical diagnosis. If foregoing biopsy then tumor board will estimate tumor stage based on clinical presentation and radiographic findings.
- Completion of all previous therapy (including surgery and radiotherapy) for the treatment of cancer >= 4 weeks before the start of study therapy.
- Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocolspecified laboratory tests, other study procedures, and study restrictions.
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- Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.
- Patients must have adequate organ and marrow function, within 28 days of Cycle 1 Day 1 of Temozolomide, as defined below:
- Hematology:
- Hemoglobin >= 9.0 g/dl (no transfusions allowed within 7 days of cycle 1 day 1 to meet entry criteria) (within 28 days of cycle 1 day 1 of temozolomide)
- White blood cell (WBC) >= 2000/uL (after at least 7 days without growth factor support or transfusion) (within 28 days of cycle 1 day 1 of temozolomide)
- Absolute neutrophil count (ANC) >= 1,500/mcL (after at least 7 days without growth factor support or transfusion) (within 28 days of cycle 1 day 1 of temozolomide)
- Platelets >= 100,000/mcL (no transfusions allowed within 7 days of cycle 1 day 1 to meet entry criteria) (within 28 days of cycle 1 day 1 of temozolomide)
- Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) (within 28 days of cycle 1 day 1 of temozolomide)
- Chemistry
- Total bilirubin =< 2 institutional upper limit of normal (ULN) (within 28 days of cycle 1 day 1 of temozolomide)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 institutional upper limit of normal (ULN) (within 28 days of cycle 1 day 1 of temozolomide)
- Serum creatinine =< 2 mg/dL (or glomerular filtration rate >= 40 mL/min) (within 28 days of cycle 1 day 1 of temozolomide)
- The effects of combination therapy with tumor treating fields (TTF) and temozolomide on the developing human fetus are unknown. For this reason and because other therapies used in this trial are known to be teratogenic, female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy.
- FCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 12 months after completion of TTF and Temozolomide administration. A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Patients who have completed chemotherapy or radiotherapy more than 26 weeks prior to entering the study.
- Completion of radiotherapy 8-12 weeks prior to starting the tumor treating fields will be considered a minor deviation.
- Completion of radiotherapy 13-26 weeks prior to starting the tumor treating fields will be considered a major deviation.
- Patients who are receiving any other investigational agents or an investigational device within 21 days before first administration of study device.
- History of allergic reactions attributed to compounds of similar composition to those used for transducer placement.
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- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Significant cardiovascular disease (eg, myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to start of study therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; or uncontrolled Grade ≥3 hypertension (diastolic blood pressure ≥100 mmHg or systolic blood pressure ≥160 mmHg) despite antihypertensive therapy.
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of increased risk of lethal infections when treated with marrow-suppressive therapy such as Temozolomide. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
Emory Proton Therapy Center
Atlanta, Georgia, 30308
India Green, 404-778-1738, india.eunhye.green@emoryhealthcare.org
Jim Zhong, MD
- Recruiting
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322
India Green, 404-778-1738, india.eunhye.green@emoryhealthcare.org
Jim Zhong, MD
- Not yet recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
India Green, 404-778-1738, india.eunhye.green@emoryhealthcare.org
Jim Zhong, MD
About this study
Official title: Tumor Treating Fields: Pilot Study of Adjuvant Treatment for Brainstem Gliomas
This clinical trial tests the safety and side effects of tumor treating fields in treating patients with gliomas located in the brainstem. Optune is a wearable, portable, treatment that creates low-intensity, wave-like electric fields called tumor treating fields (TTFields), which interfere with cancer cell division. TTFields may prevent growth or decrease size of gliomas in patients
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the safety and tolerability of tumor treating fields in combination with standard of care radiotherapy and chemotherapy in patients with brainstem gliomas.
SECONDARY OBJECTIVE:
- To evaluate the anti-tumor activity of the combination of radiotherapy, chemotherapy, and tumor treating fields by assessing progression-free survival (PFS), overall response rate, and overall survival (OS).
TERTIARY/EXPLORATORY OBJECTIVE:
- To assess the effects of the tumor treating fields on neurocognitive function.
OUTLINE:
Beginning after start of standard of care radiation therapy, patients wear the Optune device for at least 18 hours per day for 12 months in the absence of disease progression or unacceptable toxicity.
During study treatment, patients are followed up at 3, 6, 9, and 12 months. After study treatment, patients are followed up every 3-6 months.
- Conditions
- Glioma
- Being tested
- Optune device
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optune deviceDevice
Also called Alternating Electric Field Therapy, TTF, TTFields, Tumor Treating Fields Therapy
Wear Optune device
| Study group | Role | What they receive |
|---|---|---|
| Treatment (tumor treating fields) | Experimental | 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. Receives: Device: Optune device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Adverse event rates will be summarized descriptively using frequencies and percentages in addition to a tolerability rate defined as composite of any dose-limiting toxicity.
Measured: Up to 12 months after TTFields started
Secondary outcomes (3)
Progression free survival (PFS)
PFS will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median PFS will be estimated using the Brookmeyer-Crowley approach.
Measured: From TTFields start to disease progression or death, assessed up to 36 months
Overall response rate
Evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Measured: Up to 12 months after TTFields started
Overall survival (OS)
OS will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median OS will be estimated using the Brookmeyer-Crowley approach.
Measured: From TTFields start to death from any cause, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start11 May 2022
- Primary completion1 Sep 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jim Zhong, Emory University
- Investigators
- Jim Zhong, MD, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310448
- Sponsor's protocol ID
- STUDY00003027
- Other IDs
- NCI-2021-09679, WINSHIP5412-21, P30CA138292
- Status last verified
- Oct 2026
- First submitted
- 4 Feb 2022
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Treating Fields: Pilot Study of Adjuvant Treatment for Brainstem Gliomas
- ClinicalTrials.gov ID
- NCT05310448
- Acronym / sponsor ID
- STUDY00003027
- Conditions
- Glioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 May 2022 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial tests the safety and side effects of tumor treating fields in treating patients with gliomas located in the brainstem. Optune is a wearable, portable, treatment that creates low-intensity, wave-like electric fields called tumor treating fields (TTFields), which interfere with cancer cell division. TTFields may prevent growth or decrease size of gliomas in patients
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the safety and tolerability of tumor treating fields in combination with standard of care radiotherapy and chemotherapy in patients with brainstem gliomas.
SECONDARY OBJECTIVE:
- To evaluate the anti-tumor activity of the combination of radiotherapy, chemotherapy, and tumor treating fields by assessing progression-free survival (PFS), overall response rate, and overall survival (OS).
TERTIARY/EXPLORATORY OBJECTIVE:
- To assess the effects of the tumor treating fields on neurocognitive function.
OUTLINE:
Beginning after start of standard of care radiation therapy, patients wear the Optune device for at least 18 hours per day for 12 months in the absence of disease progression or unacceptable toxicity.
During study treatment, patients are followed up at 3, 6, 9, and 12 months. After study treatment, patients are followed up every 3-6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (tumor treating fields) | Experimental | Device: Optune deviceAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Age >= 18 years
- Karnofsky performance status >= 70%
- Life expectancy > 12 weeks as determined by the investigator
- Diagnosis of glioma with at least partial involvement or invasion of thalamus, cerebral peduncles, midbrain, pons, or medulla. Confirmation of diagnosis by biopsy or maximal safe resection preferred. If multi-disciplinary tumor board recommend no benefit and likely harm of attempting biopsy then can establish consensus clinical diagnosis. If foregoing biopsy then tumor board will estimate tumor stage based on clinical presentation and radiographic findings.
- Completion of all previous therapy (including surgery and radiotherapy) for the treatment of cancer >= 4 weeks before the start of study therapy.
Key exclusion criteria (9 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Patients who have completed chemotherapy or radiotherapy more than 26 weeks prior to entering the study.
- Completion of radiotherapy 8-12 weeks prior to starting the tumor treating fields will be considered a minor deviation.
- Completion of radiotherapy 13-26 weeks prior to starting the tumor treating fields will be considered a major deviation.
- Patients who are receiving any other investigational agents or an investigational device within 21 days before first administration of study device.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optune deviceAlso: Alternating Electric Field Therapy, TTF, TTFields, Tumor Treating Fields TherapyWear Optune device | Device | Treatment (tumor treating fields) |
Primary outcome
Incidence of adverse events
Time frame: Up to 12 months after TTFields started
Adverse event rates will be summarized descriptively using frequencies and percentages in addition to a tolerability rate defined as composite of any dose-limiting toxicity.
3 secondary outcomes
Progression free survival (PFS)
Time frame: From TTFields start to disease progression or death, assessed up to 36 months
Overall response rate
Time frame: Up to 12 months after TTFields started
Overall survival (OS)
Time frame: From TTFields start to death from any cause, assessed up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jim Zhong, MD principal investigator
Emory University Hospital/Winship Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optune device in people with Glioma, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jim Zhong, MD (404-778-3473, jzhong@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Up to 12 months after TTFields started). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.