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NCT06346821Completed

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

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

Source: ClinicalTrials.gov · Last updated 3 Jul 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
181 (actual)
First submitted
29 Mar 2024
Start date
22 Nov 2022
Primary completion date
1 Apr 2024
Lead sponsor
Sichuan University
Diseases
Glioblastoma
NCT number
NCT06346821

What you commit to

  • Study type: Observational
  • Participants enrolled: 181
  • From 22 Nov 2022 to the primary completion date, 1 Apr 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Progressive disease (per investigator's assessment).
  • Infratentorial or leptomeningeal disease.
  • Any serious surgical/post-operative condition that may risk the patient according to the investigator.

Other

  • Significant co-morbidities at baseline which would preclude maintenance RT or TMZ treatment.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
West China Hospital
Coordinator of this site? Confirm its status
ChengduChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.