Back to resultsA Phase III Study of Postoperative Early Temozolomide Treatment Plus STUPP Regimen for Newly Diagnosed GBM Multiforme
Primary Purpose
Anaplastic Oligoastrocytoma, Glioblastoma
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Temozolomide
Sponsored by
About this trial
This is an interventional treatment trial for Anaplastic Oligoastrocytoma focused on measuring Glioblastoma Multiforme, chemotherapy, Temozolomide
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.
Sites / Locations
- Sun Yat-sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Early TMZ chemotherapy
Arm Description
Patients were treated with standard concomitant radiochemotherapy regimen (Stupp) plus early postsurgical temozolomide.
Outcomes
Primary Outcome Measures
Overall survival
Overall survival
Secondary Outcome Measures
Progression free survival
Progression free survival
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
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
Full Information
NCT ID
NCT05600491
First Posted
October 27, 2022
Last Updated
October 27, 2022
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT05600491
Brief Title
A Phase III Study of Postoperative Early Temozolomide Treatment Plus STUPP Regimen for Newly Diagnosed GBM Multiforme
Official Title
A Phase III Study of Postoperative Early Temozolomide Treatment Plus STUPP Regimen for Newly Diagnosed GBM Multiforme
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2015 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaplastic Oligoastrocytoma, Glioblastoma
Keywords
Glioblastoma Multiforme, chemotherapy, Temozolomide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early TMZ chemotherapy
Arm Type
Experimental
Arm Description
Patients were treated with standard concomitant radiochemotherapy regimen (Stupp) plus early postsurgical temozolomide.
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Other Intervention Name(s)
Temodar, TMZ
Intervention 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).
Primary Outcome Measure Information:
Title
Overall survival
Description
Overall survival
Time Frame
5-year
Secondary Outcome Measure Information:
Title
Progression free survival
Description
Progression free survival
Time Frame
5-year
Title
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
Description
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
Time Frame
5-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mou Y Gao, MD, PhD
Phone
+86-20-87343821
Email
Mouyg@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Guo C Cheng, MD, PhD
Phone
+86-20-87343309
Email
guochch@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mou Y Gao, MD, PhD
Organizational Affiliation
Department of Neurosurgery/Neuro-oncology, Sun Yat-sen University Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mou Y Gao, MD, PhD
Phone
+86-20-87343821
Email
Mouyg@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Guo C Cheng, MD, PhD
Phone
+86-20-87343309
Email
guochch@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Mou Y Gao, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
A Phase III Study of Postoperative Early Temozolomide Treatment Plus STUPP Regimen for Newly Diagnosed GBM Multiforme
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