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Effect of Radiotherapy Concurrent of TTFields in Patients With Glioblastoma

Study Purpose

TTFields has been approved by the FDA for the treatment of patients with glioblastoma multiforme. However, the clinical effect and safety of radiotherapy concurrent of TTFields is not definite. In this study, the investigators conduct a phase II clinical trial to evaluate the efficacy and safety of this strategy.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - performance status of 0-1 (Eastern Cooperative Oncology Group performance status) - histologically confirmed glioblastoma.
  • - no cerebrospinal fluid and distant metastatic disease.

Exclusion Criteria:

  • - with a history of brain radiotherapy.
- severe hepatic and renal dysfunction

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04902586
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Zhongnan Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jianyin Huang, MD
Principal Investigator Affiliation Wuhan University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Unknown status
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioma, Glioblastoma
Additional Details

the investigators plan to recruit 30 patients to evaluate the efficacy and safety of this strategy.

Arms & Interventions

Arms

Experimental: E group

All patients received chemoradiotherapy (CRT) ( PTV-GTV: 60Gy at 2.0Gy per fraction, 5 fractions per week for 6 weeks; PTV-CTV: 54Gy at 1.8Gy per fraction, 5 fractions per week for 6 weeks) with a Temozolomide (TMZ) regimen(75mg/m2 per day during RT)and TTFields therapy during RT. The TTFields therapy started on the day the radiotherapy started.

No Intervention: C group

All patients received chemoradiotherapy (CRT) ( PTV-GTV: 60Gy at 2.0Gy per fraction, 5 fractions per week for 6 weeks; PTV-CTV: 54Gy at 1.8Gy per fraction, 5 fractions per week for 6 weeks) with a Temozolomide (TMZ) regimen(75mg/m2 per day during RT)

Interventions

Device: - TTFields

The TTFields, consisting of low-intensity, 200 kHz frequency, alternating electric fields, was delivered (≥ 18 hours/d) via 4 transducer arrays on the shaved scalp and connected to a portable device.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Zhongnan hospital, Wuhan, Hubei, China

Status

Address

Zhongnan hospital

Wuhan, Hubei,

Site Contact

Yahua Zhong, phd

[email protected]

08602767813154