A Phase III Study of Postoperative Early Temozolomide Treatment Plus STUPP Regimen for Newly Diagnosed GBM Multiforme

Study Purpose

This study was to explore the effectiveness and safety of early TMZ chemotherapy between surgery and chemoradiotherapy plus the standard concomitant radiochemotherapy regimen.

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:

Age: 18 years to 70 years; Newly diagnosed Glioblastoma in the supratentorial cerebral hemisphere; Gross total resection or large resection of >70% in imaging studies; Eastern Cooperative Oncology Group performance status of 0-2; Adequate bone marrow, liver and renal function; Ability of subject to understand character and individual consequences of the clinical trial Written informed consent; anticipating survival ≥7 months.

Exclusion Criteria:

Refusal to participate the study; Current diagnosis or history of malignancies within the 3-year period preceding enrollment; Recurrent or multiple malignant gliomas, including gliomatosis cerebri, or metastatic extracalvarial or subtentorial lesions; Known hypersensitivity or contraindication to temozolomide; Pregnant or lactating females; Malignant tumor other than brain tumor; Contraindicated for MRI examination; Unable to comply with the follow-up studies of this trial; Uncontrolled psychotic disorders or epilepsy.

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.	NCT05600491
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.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sun Yat-sen University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Mou Y Gao, MD, PhD
Principal Investigator Affiliation	Department of Neurosurgery/Neuro-oncology, Sun Yat-sen University Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Anaplastic Oligoastrocytoma, Glioblastoma

Additional Details

This study was to explore the effectiveness and safety of early temozolomide chemotherapy between surgery and chemoradiotherapy plus the standard concomitant radiochemotherapy regimen. Patients were treated with a standard therapy regimen (Stupp) plus early postsurgical temozolomide.

Arms & Interventions

Arms

Experimental: Early TMZ chemotherapy

Patients were treated with standard concomitant radiochemotherapy regimen (Stupp) plus early postsurgical temozolomide.

Interventions

Drug: - Temozolomide

Two weeks after surgery, temozolomide was administered orally at 200 mg·m-2 ·d -1 for 5 days. From day 29, patients were treated with a standard therapy regimen (Stupp).

Contact a Trial Team

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International Sites

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

Status

Recruiting

Address

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060

Site Contact

Mou Y Gao, MD, PhD

Mouyg@sysucc.org.cn

+86-20-87343821

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