Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-24 @ 10:30 PM
NCT ID:
NCT02520635
Brief Summary:
The primary purpose of the study is to evaluate the efficacy and safety of supra-early post-surgery chemotherapy versus standard TEMODAL® regimen in treatment of patients with newly diagnosed glioblastoma multiforme. The secondary purpose is to assess the efficacy of supra-early post-surgery chemotherapy in release brain edema.
Detailed Description:
Glioblastoma (GBM) is the most common primary malignant brain tumor. Despite great efforts have been devoted to promoting the treatment effect, GBM remains one of the most lethal tumors concurrent with poor prognosis and inevitable recurrence. The standard treatment protocol for GBM includes surgical resection, radiotherapy and temozolomide (TMZ) based chemotherapy. TMZ, an alkylating agent, has been proved to be efficient to control tumor growth after surgery and gradually has been recognized in routine clinical course for GBM. In a pivotal clinical trial published in 2005, GBM patients received concomitant TMZ and radiotherapy followed by 6 periods of adjuvant TMZ chemotherapy had a median survival of 14.6 months and 5-year survival rate of 9.8%, which has been regarded as a landscape in treatment history of GBM. To date, this regimen remains the standard protocol for newly diagnosed GBM patients. However, the optimal timing of initiation of TMZ or radiotherapy remains unclear. Our previous study showed 75mg per square meter of body surface per day (mg/m2/d) of TMZ chemotherapy alone was effective to control post-operative edema caused by tumor cell infiltration in primary GBM patients. The result suggested anti-cancer agents such as TMZ may be a useful regimen to control tumor cell regrowth after operation. Therefore, we conducted this prospective clinical trial to testify the hypothesis that supra-early initiation of TMZ chemotherapy in newly diagnosed GBM patients is effective to control tumor growth after tumor resection and therefore improve patients'clinical outcome.
Study:
NCT02520635
Study Brief:
Protocol Section:
NCT02520635