Tumor Treating Fields for Newly Diagnosed Glioblastoma: Two Emulated Trials With Chinese Multi-Hospital Based Real-World Data

NCT06346821 | Completed DMC FDA Device

• 1 other identifier: WestChinaGBMTTFieldsV1.0
• Study Type: observational
• Target: 181
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the effectiveness of Optune® (Tumor Treating Fields) in newly diagnosed glioblastoma (GBM) in China. The main question it aims to answer are:

• The efficacy of Optune® as an concomitant/adjuvant to radiation therapy (RT) and temozolomide (TMZ) alone in the treatment of newly diagnosed GBM patients.
• The effectiveness of Optune® given concomitantly with RT and TMZ in newly diagnosed GBM patients, compared to RT and TMZ alone. Participants will:
• Receive or not receive TTFields.
• Concomitantly or adjuvantly receive TTFields.

Conditions

Glioblastoma Multiforme

Keywords

Glioblastoma; Tumor Treating Fields; Real-world; Concomitant; Adjuvant; Overall survival

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Survival will be measured from the time of randomization until date patient is alive.

  5 years

Study Arms (4)

TTFields-Total

Patients receive standard RT + TMZ, followed by maintenance TMZ, with Optune® starts during peri-radiotherapy period (2 month before to 3 months after radiotherapy). The duration of TTFields lasts for at least 2 months.

Device: Optune® (Tumor Treating Fields)

Active Comparator: Temozolomide alone

Patients receive RT and TMZ alone, followed by maintenance TMZ.

TTFields-concomitant

Patients receive TTFields at 200 kHz to the brain using the Optune® System together with RT and TMZ, followed by maintenance TMZ concomitant with the Optune® treatment. The duration of TTFields lasts for at least 2 months. If the subject is assigned to this treatment arm, Optune® therapy will begin no later than the 7th day of RT and TMZ treatment.

Device: Optune® (Tumor Treating Fields)

TTFields-adjuvant

Patients receive RT and TMZ alone, followed by maintenance TMZ concomitant with TTFields at 200 kHz to the brain using the Optune® within 3 months after radiotherapy for at least 2 months.

Device: Optune® (Tumor Treating Fields)

Interventions

Optune® (Tumor Treating Fields) DEVICE

TTFields at 200 kHz to the brain using the Optune® System

TTFields-Total; TTFields-adjuvant; TTFields-concomitant

Eligibility Criteria

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

Study Population

Patients who are diagosed and whose surgery and radiotheraoy are finished in West China Hospital, Sichuan Cancer Hospital, Shenzhen People's Hospital, Henan Cancer Hospital, The First Affiliated Hospital of Xi'an Jiaotong University, The First Affiliated Hospital of Zhengzhou University

You may qualify if:

• Histologically confirmed diagnosis of GBM according to WHO classification criteria.
• Age ≥ 18 years.
• Recovered from maximal debulking surgery.
• Karnofsky performance status ≥ 60.
• Planned treatment with RT/TMZ followed by maintenance TMZ.

You may not qualify if:

• Progressive disease (per investigator's assessment).
• Infratentorial or leptomeningeal disease.
• Significant co-morbidities at baseline which would preclude maintenance RT or TMZ treatment.
• Any serious surgical/post-operative condition that may risk the patient according to the investigator.

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

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 Officials

• Lei Liu, PhD, MD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: November 22, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE

Locations

CN (1)