TTFields and Radiosurgery of Recurrent Glioblastoma +/- 18F-Fluoro-Ethyl-Thyrosine
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Glioblastoma Multiforme
- Recurrent Glioblastoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: This is an open-label, phase II trial enrolling participants with recurrences or progressive tumor, who will be treated with radiosurgery and TTFields. The investigators will attempt to enroll the maximum number of patients and expect to enroll 40 subjects. All subjects will receive TTFields and radiosurgery plus/minus FET PET imaging to define tumor volume.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Almost all GBM patients experience recurrent disease. Stereotactic radiosurgery (SRS),at recurrence, has limitations due to the invasive nature of glioblastoma. TTFields may decrease the tumor aggressiveness outside the target area potentially by multiple pathways, including immunogenic cell death a...
Almost all GBM patients experience recurrent disease. Stereotactic radiosurgery (SRS),at recurrence, has limitations due to the invasive nature of glioblastoma. TTFields may decrease the tumor aggressiveness outside the target area potentially by multiple pathways, including immunogenic cell death and DNA repair inhibition sensitizing to radiation. We hypothesize that combined SRS and TTFields will be complementary, improving outcomes with minimal toxicity. In this open-label, phase II trial 40 participants with recurrence will be treated with SRS and TTFields, starting in 2020. Recurrence will be defined on FET-PET or MRI using RANO criteria. All patients will begin treatment within 14 days from baseline imaging evaluation and at maximum 42 days from screening. The attempt to obtain the Methyl-guanine methyl-transferase (MGMT) gene promoter methylation and IDH1 and IDH2 mutation from primary tumor are made during the study whenever not defined before entering to the study. TTFields treatment will be initiated as in clinical routine at patients home. Admission to hospital will not be necessary. SRS must be delivered within 7 days of TTFields start. A 5-day SRS regimen is allowed. TTFields should be interrupted only during SRS. The sample size of the study was calculated for the comparison of survival against a historical control.Overall survival will be stratified by volume, PET-based treatment, SVZ invasion, MGMT methylation status, time to first progression, and TTFields compliance.
Tracking Information
- NCT #
- NCT04671459
- Collaborators
- NovoCure GmbH
- Investigators
- Principal Investigator: Maciej Harat, MD PhD Prof. Franciszek Lukaszczyk Memorial Oncology Center
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