NCT02520635

Supra-early Post-Surgery Chemotherapy in the Treatment on GBM Patients

A Clinical Study of Supra-early Post-Surgery Chemotherapy Plus Standard TEMODAL® Regimen Versus Standard TEMODAL® Regimen in the Treatment on Patients With Newly Diagnosed Glioblastoma Multiforme

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 180 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	supra-early TEMODAL® chemotherapy
DRUG	standard TEMODAL® chemotherapy
RADIATION	Radiotherapy 60Gy

Timeline

• Start date: 2015-01-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2015-08-13
• Last updated: 2019-07-11

Locations

1 site across 1 country: China