Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Timing of Tumor-Treating Fields Plus Short-Course Radiation (GERAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04218019
Recruitment Status : Not yet recruiting
First Posted : January 6, 2020
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Juergen Debus, University Hospital Heidelberg

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.


Condition or disease Intervention/treatment Phase
Newly Diagnosed Glioblastoma in Patients ≥70 Years Device: TTFields Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Timing of Tumor-Treating Fields Plus Short-Course Radiation in Elderly Patients With Glioblastoma
Estimated Study Start Date : August 1, 2021
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early Tumor Treating Fields (TTFields, Optune®) treatment
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
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.

Active Comparator: Late TTF treatment
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
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.




Primary Outcome Measures :
  1. Safely conducted therapy rate (SCTR) [ Time Frame: at least one week of treatment ]
    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

  2. Number of participants with treatment related adverse events as assessed by CTCAE V 5.0. [ Time Frame: within 31 weeks after treatment ]
    Safety and tolerability of TTFields Treatment combined with radiotherapy/chemo-radiotherapy


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: within 6 month after treatment ]
    according to RANO criteria

  2. 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. [ Time Frame: within 31 weeks after treatment ]
    Score on the EORTC QoL C15-Pal

  3. 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. [ Time Frame: within 31 weeks after treatment ]
    Score on the EORTC QoL BN20



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04218019


Contacts
Layout table for location contacts
Contact: Jürgen Debus, Prof. 06221 56 ext 8201 juergen.debus@med.uni-heidelberg.de

Locations
Layout table for location information
Germany
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, Germany, 69120
Sponsors and Collaborators
Juergen Debus
Investigators
Layout table for investigator information
Principal Investigator: Jürgen Debus, Prof. Head of Department
Layout table for additonal information
Responsible Party: Juergen Debus, Head of Department, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT04218019    
Other Study ID Numbers: GERAS
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue