Clinical Trial Details
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NCT02629757 : A Study on ß-elemene as Maintain Treatment for Newly Diagnosed Malignant Gliomas
PhasePhase 3
AgesMin: 18 Years Max: 75 Years
Inclusion Criteria:

- - Page 3 of 4 [DRAFT] - Arms Assigned Interventions

- Temodar Experimental: temozolomide +a-IFN Four weeks after radiotherapy, patients
will be received 6 cycle of temozolomide plus a-IFN a-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: a-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

- Karnofsky Performance Score = 60

- Adequate bone marrow, liver and renal function

- Ability of subject to understand character and individual consequences of the clinical

- 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
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