A Phase III Study of Postoperative Early Temozolomide Treatment Plus STUPP Regimen for Newly Diagnosed GBM Multiforme
1 other identifier
interventional
78
1 country
1
Brief Summary
This study was to explore the effectiveness and safety of early TMZ chemotherapy between surgery and chemoradiotherapy plus the standard concomitant radiochemotherapy regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2015
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 8, 2015
CompletedFirst Submitted
Initial submission to the registry
October 27, 2022
CompletedFirst Posted
Study publicly available on registry
October 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedOctober 31, 2022
October 1, 2022
7.1 years
October 27, 2022
October 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
Overall survival
5-year
Secondary Outcomes (2)
Progression free survival
5-year
Time to Deterioration (TTD) in Global Health Status/Health Related Quality of Life According to European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) v3.0 in All Randomized Participants
5-year
Study Arms (1)
Early TMZ chemotherapy
EXPERIMENTALPatients were treated with standard concomitant radiochemotherapy regimen (Stupp) plus early postsurgical temozolomide.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mou Y Gao, MD, PhD
Department of Neurosurgery/Neuro-oncology, Sun Yat-sen University Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Chair, Department of Neurosurgery, Sun Yat-sen University
Study Record Dates
First Submitted
October 27, 2022
First Posted
October 31, 2022
Study Start
November 8, 2015
Primary Completion
December 1, 2022
Study Completion
December 1, 2025
Last Updated
October 31, 2022
Record last verified: 2022-10