JOURNAL ONKOLOGIE – STUDIE
GERAS Effect of Timing of Tumor-Treating Fields Plus Short-Course Radiation
Noch nicht rekrutierend
NCT-Nummer:
NCT04218019
Studienbeginn:
August 2021
Letztes Update:
11.09.2020
Wirkstoff:
-
Indikation (Clinical Trials):
Glioblastoma
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 2
Sponsor:
Juergen Debus
Collaborator:
-
Studienleiter
Principal Investigator
Head of Department
Kontakt
Kontakt:
Phone: 06221 56
Phone (ext.): 8201
E-Mail: juergen.debus@med.uni-heidelberg.de» Kontaktdaten anzeigen
Studienlocations (1 von 1)
University Hospital of Heidelberg, Radiation Oncology
69120 Heidelberg
(Baden-Württemberg)
Germany» Google-Maps
69120 Heidelberg
(Baden-Württemberg)
Germany» Google-Maps
Studien-Informationen
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.
Ein-/Ausschlusskriterien
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
Studien-Rationale
Primary outcome: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:
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
Studien-Arme
- 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. - 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.
Geprüfte Regime
- 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.
Quelle: ClinicalTrials.gov
