Back to resultsA Phase III Trial on Adjuvant Temozolomide With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas
Primary Purpose
Anaplastic Oligoastrocytoma, Anaplastic Astrocytoma, Glioblastoma
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Temozolomide
α-IFN
Sponsored by
About this trial
This is an interventional treatment trial for Anaplastic Oligoastrocytoma focused on measuring High-grade glioma, chemotherapy, Temozolomide, Interferon-alpha
Eligibility Criteria
Inclusion Criteria:
- Age: 18 years to 75 years
- newly diagnosed WHO III-IV glioma after operation and radiotherapy
- Karnofsky Performance Score ≥ 60
- 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 ≥2 months
Exclusion Criteria:
- Refusal to participate the study
- Known hypersensitivity or contraindication to temozolomide
- Incompletely radiation
- 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
- Purulent and chronic infected wounds
- Uncontrolled psychotic disorders or epilepsy
Sites / Locations
- Sun Yat-sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
temozolomide
temozolomide +α-IFN
Arm Description
Four weeks after radiotherapy, patients will be received 6 cycle of temozolomide (150 mg/m^2 daily on Days 1-5 of each 28 day study cycle and 200 mg/m^2 daily of subsequent cycles)
Four weeks after radiotherapy, patients will be received 6 cycle of temozolomide plus α-IFN α-IFN：3mIU (3million) Day1,3,5 of each 28 day TMZ：150 mg/m^2 daily on Days 2-6 of each 28 day study cycle and 200 mg/m^2 daily of subsequent cycles
Outcomes
Primary Outcome Measures
Over-all survival
Secondary Outcome Measures
Quality of life
Full Information
NCT ID
NCT01765088
First Posted
January 7, 2013
Last Updated
February 21, 2018
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT01765088
Brief Title
A Phase III Trial on Adjuvant Temozolomide With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas
Official Title
A Phase III Trial on Adjuvant Standard Temozolomide Chemotherapy With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is being conducted to help determine whether the addition of Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in vivo and vitro, when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly diagnosed high-grade glioma.
Detailed Description
This study is being conducted to help determine whether the addition of Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in vivo and vitro, when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly diagnosed high-grade glioma. Four weeks after radiotherapy, newly diagnosed WHO III-IV glioma patients will be randomised into two groups: TMZ group or TMZ+ α-IFN groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaplastic Oligoastrocytoma, Anaplastic Astrocytoma, Glioblastoma
Keywords
High-grade glioma, chemotherapy, Temozolomide, Interferon-alpha
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
temozolomide
Arm Type
Active Comparator
Arm Description
Four weeks after radiotherapy, patients will be received 6 cycle of temozolomide (150 mg/m^2 daily on Days 1-5 of each 28 day study cycle and 200 mg/m^2 daily of subsequent cycles)
Arm Title
temozolomide +α-IFN
Arm Type
Experimental
Arm Description
Four weeks after radiotherapy, patients will be received 6 cycle of temozolomide plus α-IFN α-IFN：3mIU (3million) Day1,3,5 of each 28 day TMZ：150 mg/m^2 daily on Days 2-6 of each 28 day study cycle and 200 mg/m^2 daily of subsequent cycles
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Other Intervention Name(s)
Temodar
Intervention Description
dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days
Intervention Type
Drug
Intervention Name(s)
α-IFN
Other Intervention Name(s)
INTRONA
Intervention Description
3mIU (3million) D1，3，5
Primary Outcome Measure Information:
Title
Over-all survival
Time Frame
5-year
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
5-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 18 years to 75 years
newly diagnosed WHO III-IV glioma after operation and radiotherapy
Karnofsky Performance Score ≥ 60
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 ≥2 months
Exclusion Criteria:
Refusal to participate the study
Known hypersensitivity or contraindication to temozolomide
Incompletely radiation
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
Purulent and chronic infected wounds
Uncontrolled psychotic disorders or epilepsy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhong-ping CHEN, MD, PhD
Phone
+86-20-87343310
Email
chenzhp@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Cheng-cheng GUO, MD, PhD
Phone
+86-20-87343309
Email
guochch@sysucc.org.cn
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
Zhong-ping Chen, MD,PhD
Phone
+86-20-87343310
Email
chenzhp@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Cheng-cheng Guo, MD,PhD
Phone
+86-20-87343656
Email
guochch@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Zhong-ping Chen, MD,PhD
12. IPD Sharing Statement
Learn more about this trial
A Phase III Trial on Adjuvant Temozolomide With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas
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