Optune(NOVOTTF-100A)+ Bevacizumab+ Hypofractionated Stereotactic Irradiation Bevacizumab-Naive Recurrent Glioblastoma (GCC 1344)
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|ClinicalTrials.gov Identifier: NCT01925573|
Recruitment Status : Recruiting
First Posted : August 19, 2013
Last Update Posted : July 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|RECURRENT GLIOBLASTOMA Brain Tumor||Device: Optune(NOVOTTF-100A)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Proposed Pilot Study of Combined Optune+ Bevacizumab, and Hypofractionated Stereotactic Irradiation for Bevacizumab-Naive Recurrent Glioblastoma|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2026|
Bevacizumab every 2 weeks plus Optune daily for 4 week cycles.
RT will begin post 3 round of Bevacizumab (hypofractionated radiotherapy: 30 Gy in 5 fractions or 35 Gy in 10 fractions) per physician choice.
Adjuvant Bevacizumab and Optune
- Number of Adverse Events with a grade 3 or high toxicity (Primary Measure) [ Time Frame: 6 months ]
The ability to complete protocol treatment (i.e. tri-modality treatment) without undue acute toxicity as defined below
- : <40% rate of Grade 3 or higher nonhematologic toxicity.
- : <15% rate of Grade 4 or higher nonhematologic toxicity
- : <5% rate of Grade 4+ scalp dermatitis
- : <50% rate of Grade 2-3 scalp dermatitis
Early stopping rules: Two or more Grade 2 or higher symptomatic CNS hemorrhages; Eight treatment-related Grade 3 or higher non hematologic or Grade 4 or higher hematologic toxicities.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01925573
|Contact: Young Kwok, MDfirstname.lastname@example.org|
|Contact: Caroline Poff, RNemail@example.com|
|United States, Maryland|
|Baltimore, Maryland, United States, 21201|
|Contact: Young Kwok, MD 410-369-5239 firstname.lastname@example.org|
|Principal Investigator: Young Kwok, MD|
|Sub-Investigator: Minesh Mehta, MD|
|Principal Investigator:||Kwok Young, MD||University of Maryland|