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Trial Title:
A Phase III Study of Postoperative Early Temozolomide Treatment Plus STUPP Regimen for Newly Diagnosed GBM Multiforme
NCT ID:
NCT05600491
Condition:
Anaplastic Oligoastrocytoma
Glioblastoma
Conditions: Official terms:
Glioblastoma
Temozolomide
Conditions: Keywords:
Glioblastoma Multiforme
chemotherapy
Temozolomide
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Temozolomide
Description:
Two weeks after surgery, temozolomide was administered orally at 200 mg·m-2 ·d -1 for 5
days. From day 29, patients were treated with a standard therapy regimen (Stupp).
Arm group label:
Early TMZ chemotherapy
Other name:
Temodar
Other name:
TMZ
Summary:
This study was to explore the effectiveness and safety of early TMZ chemotherapy between
surgery and chemoradiotherapy plus the standard concomitant radiochemotherapy regimen.
Detailed 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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Mou Y Gao, MD, PhD
Phone:
+86-20-87343821
Email:
Mouyg@sysucc.org.cn
Contact backup:
Last name:
Guo C Cheng, MD, PhD
Phone:
+86-20-87343309
Email:
guochch@sysucc.org.cn
Investigator:
Last name:
Mou Y Gao, MD, PhD
Email:
Principal Investigator
Start date:
November 8, 2015
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05600491
