Back to resultsA Study on β-elemene as Maintain Treatment for Newly Diagnosed Malignant Gliomas (β-elemene)
Primary Purpose
Anaplastic Oligoastrocytoma, Anaplastic Astrocytoma, Glioblastoma
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
β-elemene
Sponsored by
About this trial
This is an interventional treatment trial for Anaplastic Oligoastrocytoma focused on measuring High-grade glioma, chemotherapy, β-elemene
Eligibility Criteria
Inclusion Criteria:
- Page 3 of 4 [DRAFT] - Arms Assigned Interventions
- Temodar Experimental: temozolomide +α-IFN 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 Drug: Temozolomide dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days
Other Names:
• Temodar Drug: α-IFN 3mIU (3million) D1，3，5
Other Names:
Minimum Age: 18 Years Maximum Age: 75 Years Gender: Both Accepts Healthy Volunteers?: No
Criteria: Inclusion Criteria:
- Age: 18 years to 75 years
- complete remission patients of newly diagnosed WHO III-IV glioma following standard treatment
- 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
- progression disease
Sites / Locations
- Sun Yat-sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
β-elemene
Arm Description
β-elemene 600mg/d,ivdrip,d1-14,every 28 days for 1 cycle, totally 6 cycles.
Outcomes
Primary Outcome Measures
Over-all survival
Secondary Outcome Measures
Quality of life
Full Information
NCT ID
NCT02629757
First Posted
December 10, 2015
Last Updated
February 21, 2018
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT02629757
Brief Title
A Study on β-elemene as Maintain Treatment for Newly Diagnosed Malignant Gliomas
Acronym
β-elemene
Official Title
A Study on β-elemene as Maintain Treatment for Complete Remission Patients of Newly Diagnosed Malignant Gliomas Following Standard Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is being conducted to help determine whether β-elemene as maintain treatment for complete remission patients of newly diagnosed malignant gliomas following standard treatment, is able to delay tumor growth, or impact how long people with newly diagnosed high-grade glioma.
Detailed Description
This study is being conducted to help determine whether β-elemene as maintain treatment for complete remission patients of newly diagnosed malignant gliomas following standard treatment, is able to delay tumor growth, or impact how long people with newly diagnosed high-grade glioma. β-elemene will be given 600mg/d,d1-14,q28 days for 6 cycles.
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, β-elemene
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
β-elemene
Arm Type
Experimental
Arm Description
β-elemene 600mg/d,ivdrip,d1-14,every 28 days for 1 cycle, totally 6 cycles.
Intervention Type
Drug
Intervention Name(s)
β-elemene
Intervention Description
β-elemene 600mg/d,ivdrip,d1-14,every 28 days for 1 cycle, totally 6 cycles
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:
- Page 3 of 4 [DRAFT] - Arms Assigned Interventions
Temodar Experimental: temozolomide +α-IFN 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 Drug: Temozolomide dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days
Other Names:
• Temodar Drug: α-IFN 3mIU (3million) D1，3，5
Other Names:
Minimum Age: 18 Years Maximum Age: 75 Years Gender: Both Accepts Healthy Volunteers?: No
Criteria: Inclusion Criteria:
Age: 18 years to 75 years
complete remission patients of newly diagnosed WHO III-IV glioma following standard treatment
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
progression disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhong-ping CHEN
Phone
+86-20-87343310
Email
chenzhp@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Chengceng Guo
Phone
+86-20-87343890
Email
guochch@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhong-ping CHEN
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhong-ping Chen
Phone
+86-20-87343310
First Name & Middle Initial & Last Name & Degree
Chengcheng Guo
Phone
+86-20-87343890
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study on β-elemene as Maintain Treatment for Newly Diagnosed Malignant Gliomas
We'll reach out to this number within 24 hrs