QOL-15. THE PIVOTAL TRIDENT STUDY OF TUMOR TREATING FIELDS (TTFIELDS) THERAPY WITH CHEMORADIATION, FOLLOWED BY MAINTENANCE TTFIELDS THERAPY/TEMOZOLOMIDE (TMZ), IN NEWLY DIAGNOSED GLIOBLASTOMA (NDGBM) Article Swipe
Wenyin Shi
,
Martin Glas
,
David Roberge
,
Lawrence Kleinberg
,
Suriya Jeyapalan
,
Samuel Goldlust
,
Seema Nagpal
,
Leonardo Lustgarten
,
Stephanie E. Combs
,
Ryo Nishikawa
,
David A. Reardon
,
Rachel Grossman
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1093/neuonc/noad179.0967
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1093/neuonc/noad179.0967
INTRODUCTION: TTFields are electric fields which act to disrupt processes necessary for cancer cell division and tumor progression. TTFields therapy is a noninvasive, locoregional treatment with US FDA approval for ndGBM and recurrent GBM, as well as pleural mesothelioma. TTFields therapy concomitant with maintenance TMZ is standard of care in ndGBM after chemoradiation based on the pivotal EF-14 study (NCT00916409) reporting significant improvements in progression-free survival (PFS) and overall survival (OS) vs TMZ alone. Preclinical and pilot clinical studies subsequently demonstrated that concomitant TTFields therapy also enhanced the therapeutic effect of radiotherapy (RT). TRIAL DESIGN: TRIDENT (EF-32, NCT04471844) is a pivotal multicenter study investigating TTFields therapy (200 kHz) concomitant with RT/TMZ in adult patients with histologically confirmed ndGBM. Eligibility criteria include life expectancy (≥ 3 months) and Karnofsky performance status (≥ 70). Patients (n≈950) stratified by MGMT promoter methylation status and extent of resection are randomly assigned 1:1 to receive TTFields therapy from the first day of chemoradiation (experimental arm), or approximately 4 weeks after completion of chemoradiation (control arm). All patients will receive TTFields therapy uninterrupted for 24 months, or until second disease progression (PFS2). The primary endpoint is median OS and other endpoints include survival rates at 1 and 2 years, PFS (overall, PFS2, and rates at 6 and 12 months), overall radiological response, safety, quality of life and dependence of OS on TTFields dose. The sample size is powered for a hazard ratio of < 0.8 (5% type I error). A stratified log-rank test will be used to test the hypothesis that OS is significantly improved with first line TTFields therapy/RT/TMZ vs RT/TMZ. This global study is open at sites in 11 countries.
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- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1093/neuonc/noad179.0967
- OA Status
- green
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4388588487
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4388588487Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1093/neuonc/noad179.0967Digital Object Identifier
- Title
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QOL-15. THE PIVOTAL TRIDENT STUDY OF TUMOR TREATING FIELDS (TTFIELDS) THERAPY WITH CHEMORADIATION, FOLLOWED BY MAINTENANCE TTFIELDS THERAPY/TEMOZOLOMIDE (TMZ), IN NEWLY DIAGNOSED GLIOBLASTOMA (NDGBM)Work title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2023Year of publication
- Publication date
-
2023-11-01Full publication date if available
- Authors
-
Wenyin Shi, Martin Glas, David Roberge, Lawrence Kleinberg, Suriya Jeyapalan, Samuel Goldlust, Seema Nagpal, Leonardo Lustgarten, Stephanie E. Combs, Ryo Nishikawa, David A. Reardon, Rachel GrossmanList of authors in order
- Landing page
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https://doi.org/10.1093/neuonc/noad179.0967Publisher landing page
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YesWhether a free full text is available
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-
greenOpen access status per OpenAlex
- OA URL
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https://pmc.ncbi.nlm.nih.gov/articles/PMC10640025/pdf/noad179.0967.pdfDirect OA link when available
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Medicine, Temozolomide, Oncology, Concomitant, Internal medicine, Clinical endpoint, Radiation therapy, Chemoradiotherapy, Hazard ratio, Progression-free survival, Clinical trial, Chemotherapy, Confidence intervalTop concepts (fields/topics) attached by OpenAlex
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0Total citation count in OpenAlex
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10Other works algorithmically related by OpenAlex
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