Effect of Timing of Tumor-Treating Fields Plus Short-Course Radiation

NCT04218019 | Withdrawn

• 1 other identifier: GERAS
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Newly Diagnosed Glioblastoma in Patients ≥70 Years

Outcome Measures

Primary Outcomes (2)

• Safely conducted therapy rate (SCTR)

  The proportion of patients fulfilling the inclusion/exclusion criteria who were treated for at least one week according to protocol and neither experienced neither NCI-CTC-AEs of Grade 3 nor 4

  at least one week of treatment

• Number of participants with treatment related adverse events as assessed by CTCAE V 5.0.

  Safety and tolerability of TTFields Treatment combined with radiotherapy/chemo-radiotherapy

  within 31 weeks after treatment

Secondary Outcomes (3)

• Progression-free survival

  within 6 month after treatment

• 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.

  within 31 weeks after treatment

• 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.

  within 31 weeks after treatment

Study Arms (2)

Early Tumor Treating Fields (TTFields, Optune®) treatment

EXPERIMENTAL

TTF will be started together with hypofractionated radiotherapy (+/- 5 days) with or without Temozolomide (according to the standard and local physician's decision). Chemoradiotherapy with temozolomide and hypofractionated radiotherapy is regarded as standard therapy and not part of the intervention. In case of chemoradiotherapy temozolomide will be applied according to the standard of the participating trial center. Use of antiemetic and infection prophylaxis will be at the discretion of the investigator.

Device: TTFields

Late TTF treatment

ACTIVE COMPARATOR

Patients will be treated with hypofractionated radiotherapy with or without temozolomide (according to the local standard and physician's decision). Radiotherapy and treatment with temozolomide is regarded as standard therapy and not part of the intervention. In case of chemoradiotherapy temozolomide will be applied according to the standard of the participating trial center. Use of antiemetic and infection prophylaxis will be at the discretion of the investigator. Late TTFields treatment will start 4 weeks after the end of radiotherapy.

Device: TTFields

Interventions

TTFields DEVICE

The NovoTTF-200 A device used in this trial delivers very low intensity, alternating electric fields to the tumor site through the scalp. These fields are known as Tumor Treating Fields or TTFields.

Early Tumor Treating Fields (TTFields, Optune®) treatment; Late TTF treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Juergen Debus: lead

Study Sites (1)

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, 69120, Germany

Location

Study Officials

• Jürgen Debus, Prof.

  Head of Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: January 6, 2020
• Study Start: August 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)