A Phase III Study of Postoperative Early Temozolomide Treatment Plus STUPP Regimen for Newly Diagnosed GBM Multiforme
Trial ID: NCT05600491
Interventional - Phase 3 - Unknown status
This study was to explore the effectiveness and safety of early TMZ chemotherapy between surgery and chemoradiotherapy plus the standard concomitant radiochemotherapy regimen.
Conditions
- Anaplastic Oligoastrocytoma
- Glioblastoma
Interventions
Eligibility
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.
Sponsor
Sun Yat-sen University
Source: ClinicalTrials.gov
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