MedTrace Logo

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

NCT07120620 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-08-13

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Sied Kebir

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-25
Primary Completion
2023-08-28
Completion
2023-08-28

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07120620 on ClinicalTrials.gov