PriCoTTF Study: TTFields Before and During Radiotherapy for Newly Diagnosed Glioblastoma

NCT07120620 | Completed Phase 1 DMC

• 1 other identifier: EXT-201701
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioblastoma Multiforme (GBM)

Keywords

newly-diagnosed glioblastoma; TTFields; Tumor Treating Fields; radiotherapy; chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (10)

• Long-term treatment-limiting toxicities (TLTs)

  Until the end of treatment or tumor recurrence, whichever occurs first (usually 6 to 24 months)

• Short-term treatment-limiting toxicities (TLTs)

  During (usually 3-6 weeks) radiotherapy and up to 4 weeks after the end of radiotherapy

• Progession free survival (PFS)

  Until tumor recurrence (usually 6 to 12 months)

• Overall survival (OS)

  From tumor diagnosis to death (usually 6 to 24 months)

• Radiological response (RANO criteria)

  Until the end of treatment or tumor recurrence, whichever occurs first (usually 6 to 24 months)

Other Outcomes (4)

• Exploratory endpoint: 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 (usually 6 to 12 months)

• Exploratory endpoint: Assessment of Tumor Progression Patterns

  At progression (usually 6 to 12 months)

• Exploratory endpoint: Progression free survival (PFS) from first to second tumor progression

  First to second progression (usually after 6 to 24 monts)

Study Arms (2)

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.

Device: TTFields before and during radiotherapy

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.

Device: TTFields before and during radiotherapy

Interventions

TTFields before and during radiotherapy DEVICE

Administration of TTFields before and during radiation therapy in patients with primary glioblastoma (Arm A)

Arm A: surgery, TTFields, radiotherapy and chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Pathological evidence of glioblastoma or gliosarcoma using latest World Health Organization (WHO) classification criteria
• Negative isocitrate dehydrogenase (IDH) status on immunohistochemistry or sequencing
• Patient received brain tumor resection or biopsy and further treatment regime foresees radiotherapy with or without concomitant chemotherapy
• General indication for whole treatment regimen was a common decision of a multidisciplinary team within brain tumor board and in accordance with the national and/or international guidelines for the treatment of glioblastoma patients
• KPS ≥ 60% (Study arm A), KPS ≥ 50% (Study arm B)
• Life expectancy at least 3 months
• Participants of child-bearing age must use effective contraception
• Treatment with Tumor Treating Fields (TTFields) may start 2-4 weeks post resection and 1-2 weeks prior to radiotherapy
• Subjects with the ability to follow study instructions and likely to attend and complete all required visits
• Written informed consent of the subject

You may not qualify if:

• Subjects not able to give consent
• Subject without legal capacity who is unable to understand the nature, scope, significance, and consequences of this clinical trial
• Simultaneously participation in another clinical trial or participation in any clinical trial involving administration of an investigational medicinal product within 30 days prior to clinical trial beginning
• Subjects with a physical or psychiatric condition which at the investigator´s discretion may put the subject at risk, may confound the trial results or may interfere with the subject's participation in this clinical trial
• Known or persistent abuse of medication, drugs or alcohol
• Current or planned pregnancy or nursing women
• Females of child-bearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases
• Infra-tentorial tumor
• Significant comorbidities at baseline, which would prevent possible chemotherapy, including:
• Platelet count \< 100/nl
• Absolute neutrophil count (ANC) \< 1.5/nl
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times the upper limit of normal
• Total bilirubin above the normal range
• Serum creatinine \> 1.7 mg/dl
• Patients with clinically significant liver-, renal- or blood disorder

Sponsors & Collaborators

• Sied Kebir: lead

Study Sites (1)

University Hospital Essen, Department of Neurology, Division of Clinical Neuro-Oncology

Essen, Northrhine-Westfalia, 45147, Germany

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD. Dr. med., Head of Clinical Neuro-Oncology

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: August 13, 2025
• Study Start: June 25, 2019
• Primary Completion: August 28, 2023
• Study Completion: August 28, 2023
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

DE (1)