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

Launched by SUN YAT-SEN UNIVERSITY · Oct 27, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with a type of brain cancer called glioblastoma multiforme. The study is looking at the effectiveness and safety of starting a chemotherapy drug called temozolomide (TMZ) soon after surgery, before beginning the usual combination of radiation and chemotherapy. The goal is to see if this earlier treatment can help patients live longer and improve their quality of life.

To participate in this study, patients need to be between 18 and 70 years old, have recently been diagnosed with glioblastoma, and have undergone significant surgery to remove the tumor. They should also be in good overall health and able to understand what the study involves. Participants can expect to receive close monitoring and care throughout the trial, and they will be asked to provide informed consent to ensure they understand the study's purpose and procedures. It's important to know that the trial is currently recruiting, so interested patients should discuss this option with their healthcare provider.

Gender

ALL

Eligibility 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.