NovoTTF-200A Device in Treating Patients With Newly Diagnosed High Risk Oligodendroglioma
NCT ID: NCT03353896
Last Updated: 2020-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2017-12-15
2020-12-08
Brief Summary
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Detailed Description
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I. To describe the safety and tolerability of the TTFields treatment in patients with newly diagnosed high risk oligodendroglioma following standard of care treatment.
SECONDARY OBJECTIVES:
I. To estimate the proportion of patients who tolerated 75% of treatment goal at months 6, 12, 24.
II. To estimate the progression free survival time. III. To assess quality of life. IV. To assess whether or not there is a correlation between genomics and the efficacy of the TTFields treatment.
OUTLINE:
Beginning 4-8 weeks after standard of care treatment, patients wear NovoTTF-200A device over 18 hours daily (QD). Treatment continues for up to 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 2 months and then monthly thereafter.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (medical device)
Beginning 4-8 weeks after standard of care treatment, patients wear NovoTTF-200A device over 18 hours QD. Treatment continues for up to 24 months in the absence of disease progression or unacceptable toxicity.
Wear novoTTF-200A
Wear novoTTF-200A device
Quality-of-Life Assessment
Ancillary studies
Interventions
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Wear novoTTF-200A
Wear novoTTF-200A device
Quality-of-Life Assessment
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Surgically sub-total or unresectable tumors, i.e. in insula, including but not limited to the insula and received standard of care (SOC) radiation
* Historical pathological tissue evidence of high risk oligo (low grade oligo, low grade mixed oligoastrocytoma, anaplastic oligo, anaplastic mixed oligo) by histology and or molecular classification
* 1p and 19q deletion status known
* IDH 1 \& 2 mutations status known
* MGMT status known
* Karnofsky equal or greater than 70
* Life expectancy at least 3 months
* Participants of childbearing age must use effective contraception
* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
* Has not undergone a hysterectomy or bilateral oophorectomy; or
* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
* Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria
* Tumor progression after radiation
* Pregnant
* Has implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain
* Documented clinically significant cardiac arrhythmias
* Infra-tentorial tumor
19 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
NovoCure Ltd.
INDUSTRY
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Thomas Chen, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2017-02074
Identifier Type: REGISTRY
Identifier Source: secondary_id
EF-OLIGO-15
Identifier Type: -
Identifier Source: secondary_id
6B-15-1
Identifier Type: OTHER
Identifier Source: secondary_id
6B-15-1
Identifier Type: -
Identifier Source: org_study_id