Tumor Treating Fields With Chemoradiation in Newly Diagnosed GBM

Status Terminated

Clinical Trial Summary

Clinical Trial Description

The study is an open-label pilot study in newly diagnosed glioblastoma patients following surgery. Eligible patients will receive treatment with tumor treating fields therapy using the Optune device starting less than 2 weeks prior to start of chemoradiation. Patients will receive radiation and temozolomide at a routine treatment dose and schedule. The expected toxicity is skin related, and patients will be followed closely with weekly skin and neurological examinations during radiation therapy and for 8 weeks afterwards to capture any delayed toxicity as they begin adjuvant therapy per routine treatment. As long as study treatment is tolerated and their conditions remain stable, patients will continue the treatment for up to 24 months. Prior to enrollment, an exploratory analysis of radiation dosimetry will be performed by phantom modeling incorporating the Optune arrays. The study incorporates three stages of recruitment to confirm the safety of combining tumor treating fields therapy with concurrent chemoradiation: a safety lead-in cohort of the first 6 patients enrolled, a second safety lead-in cohort of 9 patients, and an expansion cohort with 15 additional patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03705351
Study type	Interventional
Source	Providence Health & Services
Contact
Status	Terminated
Phase	Phase 1
Start date	December 2, 2019
Completion date	February 24, 2022

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