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The PriCoTTF clinical trial is related to the development and validation of the investigational product Optune®, a device for generating tumor therapy fields (TTFields) that is used in combination with radiation therapy to treat newly diagnosed glioblastoma. The trial aims to evaluate the safety of early and concurrent use of TTFields with standard radiation chemotherapy. This strategy is based on preclinical data suggesting that TTFields increase the sensitivity of tumor cells to radiation therapy. Critical components of this clinical trial include demonstrating the safety and tolerability of TTFields in combination with radiation therapy and collecting initial efficacy data. The target population consists of patients with newly diagnosed glioblastoma, with treatment beginning immediately after surgical resection and continuing for up to nine months. Follow-up examinations will be conducted at regular intervals to monitor long-term treatment success. The trial protocol was developed in accordance with the guidelines of the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP). In addition, discussions were held between the sponsor, Essen University Hospital, and the relevant regulatory authorities to ensure that the clinical trial complies with regulatory requirements and is ethically acceptable. Compliance with these standards ensures scientific validity and patient safety throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: surgery, TTFields, radiotherapy and chemotherapy | Experimental | Following diagnosis of primary glioblastoma, patients are treated with postsurgical TTFields (2-4 weeks after surgery and 1-2 weeks prior radiotherapy) followed by TTFields concomitant to radiotherapy (60 Gy will be given in 30 fractions with 2 Gy per fraction). Concomitant and adjuvant chemotherapy will be administered according to institutional standards and interdisciplinary tumor conference. |
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| Arm B: Surgery, TTFields, hypofractional radiotherapy, chemotherapy (if applicable) | Experimental | Following diagnosis of primary glioblastoma, patients are treated with postsurgical TTFields (2-4 weeks after surgery and 1-2 weeks prior radiotherapy) followed by TTFields concomitant to radiotherapy for 3 weeks (40 Gy will be given at 2,67 Gy per daily fraction). Chemotherapy will be administered according to institutional standards and interdisciplinary tumor conference. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TTFields before and during radiotherapy | Device | Administration of TTFields before and during radiation therapy in patients with primary glioblastoma (Arm A) |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and safety (frequency of predefined treatment-limiting toxicities (TLTs)) of Tumor Treating Fields (TTFields) before and concurrently with radiation therapy in patients with primary glioblastoma | The primary endpoint is safety and tolerability. It is based on the frequency of predefined treatment-limiting toxicities (TLTs), which are assessed weekly during therapy and up to four weeks after the end of radiation therapy. | From the day of surgery until 4 weeks after end of radiotherapy (usually 10-12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term treatment-limiting toxicities (TLTs) | TLT 4 weeks after radiotherapy completion until the end of treatment or tumor recurrence, whichever occurs first (overall and considering concomitant chemotherapy) | Until the end of treatment or tumor recurrence, whichever occurs first (usually 6 to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory endpoint: Frequency of grade 1-4 white matter lesions | Frequency of grade 1-4 white matter lesions at 4 weeks (Visit 4) and 6 months (Visit 7) or tumor progression (Visit P) after the end of radiotherapy until tumor progression (MRI according to visit schedule) | at 4 weeks (Visit 4) and 6 months (Visit 7) or tumor progression (Visit P) after the end of radiotherapy (usually 6 to 12 months) |
Inclusion Criteria:
Exclusion Criteria:
General Exclusion Criteria:
Exclusion criteria regarding special restrictions for females:
Indication-specific exclusion criteria:
Infra-tentorial tumor
Significant comorbidities at baseline, which would prevent possible chemotherapy, including:
Patients with clinically significant liver-, renal- or blood disorder
Patients with known additional significant neurological disease (e.g. primary seizure disorder*, dementia, progressive degenerative neurological disease, meningitis or encephalitis, hydrocephalus with increased intracranial pressure)
*Patients with brain tumor-related epilepsy, seizure-free under antiepileptic therapy are eligible
Documented allergy to conductive hydrogel (e.g. ECG (electrocardiogram) sticker or TENS (transcutaneous electrical nerve stimulation) electrodes
Active implanted medical device (e.g. deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators and programmable shunts)or documented clinically significant arrhythmias
Skull defect (e.g. missing bone with no replacement) and bullet fragments in the skull
History of hypersensitivity reaction to temozolomide or lomustine
Positive human immunodeficiency virus (HIV) Test
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Essen, Department of Neurology, Division of Clinical Neuro-Oncology | Essen | Northrhine-Westfalia | 45147 | Germany |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| TTFields before and during radiotherapy | Device | Administration of TTFields before and during radiation therapy in patients with primary glioblastoma (Arm B) |
|
| Short-term treatment-limiting toxicities (TLTs) |
TLT during treatment and up to 4 weeks after end of radiotherapy concomitant chemotherapy |
| During (usually 3-6 weeks) radiotherapy and up to 4 weeks after the end of radiotherapy |
| Progession free survival (PFS) | Time from diagnosis to MRI based tumor progression | Until tumor recurrence (usually 6 to 12 months) |
| Overall survival (OS) | Overall survival from diagnosis to death | From tumor diagnosis to death (usually 6 to 24 months) |
| Radiological response (RANO criteria) | The radiological response is assessed during regular MRI follow-up examinations. | Until the end of treatment or tumor recurrence, whichever occurs first (usually 6 to 24 months) |
| Adverse events as measured by Common Terminology Criteria for Adverse Events (CTCAE) | Adverse events are classified according to CTCAE | Until the end of treatment or tumor recurrence, whichever occurs first (usually 6 to 24 months) |
| Quality of life (QoL) | The following questionnaires are used to assess quality of life: EORTC Core Quality of Life Questionnaire [QLQ-C30], (Part A with 28 questions on a Likert scale, 28 to 112 points, Higher score means lower quality of life; Part B with 2 questions on a Likert scale, 2 to 14 points, Lower score means lower quality of life) EORTC Brain Questionaire [QLQ-BN20], (20 questions on a Likert scale; 20 to 80 points; Higher score means lower quality of life) | At end of radiotherapy (usually 3-10 weeks after randomization); 4 weeks after the end of radiotherapy; at 3, 5 and 7 months of TTFields treatment |
| Estimation number of fully compliant patients | Fully compliant is defined as: Wearing rate of TTFields must be at least 50% between randomisation and visit 4 (4 weeks after the end of radiotherapy). | Usually 7 to 12 weeks |
| Estimation of the delivered cumulative dose distribution | Estimation of the delivered cumulative dose distribution over the treatment series for each patient from the KV-image guidance data and comparison with the planned dose distribution. Dose deviations by more than 3.5% in more than 1 cm3 within the PTV or if more than 5% in less than 1 cm3 will be considered as relevant | From beginning to the end of radiotherapy (usually 3-6 weeks) |
| Number of patients with ≥ grade 3 skin toxicity (Common Terminology Criteria for Adverse Events, CTCAE) | Number of patients with ≥ grade 3 skin toxicity (CTCAE) separately into patients with high 1 and low radiation risk. 1: high risk group: patients who received a surface dose >70% of the prescribed dose within or up to 6 mm below the skin on a scalp area are of >50 cm2 | Until the end of treatment or tumor recurrence, whichever occurs first (usually 6 to 24 months) |
| Exploratory endpoint: Assessment of Tumor Progression Patterns | An investigation of tumor progression patterns will be conducted with regard to specific characteristics under experimental therapy. | At progression (usually 6 to 12 months) |
| Exploratory endpoint: Progression free survival (PFS) from first to second tumor progression | PFS from first to second tumor progression (under consideration of TTFields re-challenge) | First to second progression (usually after 6 to 24 monts) |
| Exploratory endpoint: Overall survival (OS) | OS from first to second tumor progression (under consideration of TTFields re-challenge) | First to second progression (usually 6 to 24 monts) |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |