A Study on β-elemene as Maintain Treatment for Newly Diagnosed Malignant Gliomas

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Study on β-elemene as Maintain Treatment for Complete Remission Patients of Newly Diagnosed Malignant Gliomas Following Standard Treatment

Conditions
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Anaplastic Oligoastrocytoma, Anaplastic Astrocytoma, Glioblastoma

Intervention / Treatment
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* Drug: β-elemene


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: β-elemene<br>β-elemene 600mg/d,ivdrip,d1-14,every 28 days for 1 cycle, totally 6 cycles. | Drug: β-elemene<br>* β-elemene 600mg/d,ivdrip,d1-14,every 28 days for 1 cycle, totally 6 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Over-all survival |  | 5-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 5-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High-grade glioma, chemotherapy, β-elemene