NCT07120620

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

PriCoTTF Study: A Phase I/II Study With TTFields Before and During Radiotherapy in Newly Diagnosed Glioblastoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Sied Kebir · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DEVICE	TTFields before and during radiotherapy	Administration of TTFields before and during radiation therapy in patients with primary glioblastoma (Arm A)
DEVICE	TTFields before and during radiotherapy	Administration of TTFields before and during radiation therapy in patients with primary glioblastoma (Arm B)

Timeline

• Start date: 2019-06-25
• Primary completion: 2023-08-28
• Completion: 2023-08-28
• First posted: 2025-08-13
• Last updated: 2025-08-13

Locations

1 site across 1 country: Germany