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

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

Recruiting
18-70 years
All
Phase 3

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Overview

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

Description

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.

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.

Study details
    Anaplastic Oligoastrocytoma
    Glioblastoma

NCT05600491

Sun Yat-sen University

27 January 2024

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