Clinical trial NCT04218019: Effect of Timing of Tumor-Treating Fields Plus Short-Course Radiation
Official title: Effect of Timing of Tumor-Treating Fields Plus Short-Course Radiation in Elderly Patients With Glioblastoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Newly Diagnosed Glioblastoma in Patients ≥70 Years
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess timing of TTFields use as well as safety, feasibility and preliminary efficacy of treatment with TTFields in elderly patients with newly diagnosed GBM simultaneous to RT/ CRT.

The primary aim of the trial is to establish a safely conducted therapy rate higher than 0.8 in the treatment arm.

Detailed description: Despite the immense effort made over the years with different treatment modalities, the survival of patients with newly diagnosed GBM is still very poor; no treatment is curative; and the quality of life of patients with this tumor is compromised significantly, not only by their disease but also by side effects of these rigorous treatment plans. Especially in elderly patients, a treatment modality is needed that will improve the results of current standard treatments without further impairing the quality of life of these patients for their limited life span.

The objective is to test the feasibility and timing of treatment with the TTFields device in elderly patients with newly diagnosed GBM simultaneous or subsequent to RT/ CRT.

The primary rationale to conduct this study is to improve treatment in the segment of high-grade brain tumors with the highest medical need.

All procedures regarding TTFields are representing routine clinical care within the approved use of the medical product in Germany; the present trial aims to investigate the optimal timing of TTFields use in elderly GBM patients.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed, newly diagnosed glioblastoma (astrocytoma WHO grade IV)
* Indication for hypofractionated radiotherapy or hypofractionated chemo-radiotherapy with temozolomide
* Open biopsy or resection
* Craniotomy or intracranial biopsy site must be adequately healed
* Informed consent
* Age: \>65 years
* KPS ≥50%
* Ability of subject to understand character and individual consequences of the clinical trial
* Written informed consent of participation

Exclusion Criteria:

* Concurrent participation in another competing interventional clinical trial studying a drug or treatment regimen.
* Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry
* Prior RT of the brain
* Patients who have not yet recovered from acute high-grade toxicities of prior therapies
* MRI or TTFields contraindication (e.g. cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements, certain metal implants, patients with severe skull defects such as a missing bone flap, programmable shunts)
* Known hypersensitivity to conductive hydrogels
* Pregnant and lactating women

Primary outcomes:
measure: Safely conducted therapy rate (SCTR)
timeFrame: at least one week of treatment
measure: Number of participants with treatment related adverse events as assessed by CTCAE V 5.0.
timeFrame: within 31 weeks after treatment
Secondary outcomes:
measure: Progression-free survival
timeFrame: within 6 month after treatment
measure: The correlation between the Optune device usage and the health-related quality of life of elderly patients and families undergoing this therapy in combination with radiotherapy/chemo-radiotherapy.
timeFrame: within 31 weeks after treatment
measure: The correlation between the Optune device usage and the health-related quality of life of elderly patients and families undergoing this therapy in combination with radiotherapy/chemo-radiotherapy.
timeFrame: within 31 weeks after treatment
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital of Heidelberg, Radiation Oncology
Study officials:
affiliation: Head of Department
name: Jürgen Debus, Prof.
role: PRINCIPAL_INVESTIGATOR
References: