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

Last updated: October 27, 2022
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

3

Condition

Gliomas

Astrocytoma

Treatment

N/A

Clinical Study ID

NCT05600491
Yonggao Mou
  • Ages 18-70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion

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, includinggliomatosis cerebri, or metastatic extracalvarial or subtentorial lesions; Knownhypersensitivity or contraindication to temozolomide; Pregnant or lactating females;Malignant tumor other than brain tumor; Contraindicated for MRI examination; Unable tocomply with the follow-up studies of this trial; Uncontrolled psychotic disorders orepilepsy.

Study Design

Total Participants: 78
Study Start date:
November 08, 2015
Estimated Completion Date:
December 01, 2025

Study 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.

Connect with a study center

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

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