E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Glioblastoma Multiforme (WHO grade IV brain tumor) |
Glioblastom |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10018337 |
E.1.2 | Term | Glioblastoma multiforme |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10018336 |
E.1.2 | Term | Glioblastoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective is to examine the use of non-invasive focused magnetic brain stimulation (focused TMS) as a method to potentiate the effect of chemotherapeutic treatment of GBM (TMS electrochemotherapy). Patients with debut of GBM will receive TMS as supplementary treatment to standard post-operative chemotherapy and concomitant radiotherapy. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age 18 years or older 2. Newly diagnosed and histologically confirmed GBM 3. MGMT gene methylation 4. If age < 70 years: Eligability for and ability to comply with the Stupp [4] chemo-radiotherapy regimen. 5. If age > 70: Eligibility for stand alone chemotherapeutic treatment (without radiotherapy). 6. Ability to comply with the proposed TMS treatment. 7. Use of validated anti-conception for fertile female participants in concordance with guidelines provided by the Danish Health and Medicines Authority.
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E.4 | Principal exclusion criteria |
1. Pregnancy or nursing. Fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy. 2. Conditions that may contraindicate the use of transcranial magnetic stimulation (see Safety Summary for Cervel Neurotech Clinical rTMS Devices, and Cervel Neurotech rTMS System User Manual). Specifically this will include the represent of magnetic implants in the brain, uncontrollable symptomatic epilepsy refractory to standard medication, lack of ability to comply with TMS treatment. 3. Implanted pacemaker or metal contraindicating the use of MRI-scan. 4. Participation in clinical trials, which may by the investigators’ opinion interfere with or compromise treatment efficacy or safety or the interpretation and reliability of results.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoints: 1. Time to recurrence/progression 2. Mortality rate |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
9 months interim 2 years final |
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E.5.2 | Secondary end point(s) |
Secondary endpoints: 1. Changes in tumor volume 2. Toxicity and safety (CTCAE version4.0) 3. QoL |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
9 months interim 2 years final |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Patients will be followed for 2 years or until death occurs. The experiments will be terminated when all enrolled participants have either 1) finished scheduled follow-up, 2) been excluded from the trial or 3) withdrawn consent for participation. In the case that a patient experiences unacceptable discomfort, complications or adverse effects from TMS treatment individual assessment will be performed to determine whether the subject should be excluded. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |