NCT02343549|TerminatedPhase 2ResultsDMC
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closed to accrual due to low accrual
Sponsor study identifier
Secondary identifiers
interventional
13
1 country
1
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 11, 2020
Actual (reported)Study Completion
July 11, 2020
Actual (reported)All patients will complete best standard of care radiation, temozolomide and bevacizumab (6 weeks). Within two weeks of completion of this initial treatment period, study patients will be fitted with the NovoTTF-100A System and treated continuously. They will be treated with TTFields for 12 months for an average of 18 hours per day. The patient may elect to take a treatment break for a total of 3 days per month, for each month and still be in compliance. This will consist of wearing four electrically insulated electrode arrays on the head. The patients will also continue with maintenance temozolomide/ bevacizumab.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 11, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
January 16, 2015
Actual (reported)January 22, 2015
Actual (reported)July 11, 2020
Actual (reported)July 11, 2020
Actual (reported)August 10, 2021
Actual (reported)Number of Participants With 12-Month Survival
Twelve-month survival was determined for each subject as a binary variable indicating whether or not the subject was alive at 12 months from initiation of chemoradiation. Determination of this endpoint occurs after the subject has at least 12 months of follow-up, unless they have died sooner.
Evaluated over 12 months
Overall Survival (OS)
From date of treatment start to date of death, or censored as described above; assessed for approximately 5 years
Progression Free Survival (PFS)
From date of treatment start to date of progression/death, or censored as described above; assessed for approximately 2 years.
Number of Participants With Objective Response
From enrollment to best response while on study treatment; subjects remained on treatment until disease progression or death or unacceptable toxicity (subjects were on treatment for an average of 7 months)
Number of Participants With Disease Control
From enrollment to best response while on study treatment; subjects remained on treatment until disease progression or death or unacceptable toxicity (subjects were on treatment for an average of 7 months).
Duration of Response
From date of first response to date of progression/death, or censored as described above; assessed for approximately 2 years.
Best standard of care radiation therapy (RT, 2 Gy given daily 5 days per week), temozolomide (TMZ, 75 mg/m2 administered daily), and bevacizumab (BEV, 10 mg/kg administered every 2 weeks as an IV infusion) for 6 weeks. After completion of chemoradiation, NovoTTF100A system was initiated, to be worn on average 18 hours or more a day for up to 12 months. The patients also continued with maintenance TMZ/BEV.
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Ashley Sumrall, MD
Wake Forest University Health Sciences
13 participants (actual enrollment reported by the registry).
First Submitted
January 16, 2015
First Posted
January 22, 2015
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
Avastin/Temozolomide/Irinotecan for Unresectable/Multifocal Glioblastoma Multiforme
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
July 11, 2020
Actual (reported)Study Completion
July 11, 2020
Actual (reported)Last Updated
November 3, 2022
Results First Posted
August 10, 2021
Record last verified: 2021-09
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Source: ClinicalTrials.gov.
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