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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Administration of TTFields before and during radiation therapy in patients with primary glioblastoma (Arm A)
Administration of TTFields before and during radiation therapy in patients with primary glioblastoma (Arm B)
University Hospital Essen, Department of Neurology, Division of Clinical Neuro-Oncology
Essen, Northrhine-Westfalia, Germany
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.
Time frame: From the day of surgery until 4 weeks after end of radiotherapy (usually 10-12 weeks)
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)
Time frame: Until the end of treatment or tumor recurrence, whichever occurs first (usually 6 to 24 months)
Short-term treatment-limiting toxicities (TLTs)
TLT during treatment and up to 4 weeks after end of radiotherapy concomitant chemotherapy
Time frame: 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
Time frame: Until tumor recurrence (usually 6 to 12 months)
Overall survival (OS)
Overall survival from diagnosis to death
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: Until the end of treatment or tumor recurrence, whichever occurs first (usually 6 to 24 months)
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