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A Phase III Trial on Adjuvant Standard Temozolomide Chemotherapy With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas


Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Anaplastic Oligoastrocytoma, Anaplastic Astrocytoma, Glioblastoma

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Trial Information

A Phase III Trial on Adjuvant Standard Temozolomide Chemotherapy With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Over-all survival

Outcome Time Frame:

5-year

Safety Issue:

No

Authority:

China: Food and Drug Administration

Study ID:

CSNO2012001

NCT ID:

NCT01765088

Start Date:

September 2012

Completion Date:

September 2015

Related Keywords:

  • Anaplastic Oligoastrocytoma
  • Anaplastic Astrocytoma
  • Glioblastoma
  • High-grade glioma
  • chemotherapy
  • Temozolomide
  • Interferon-alpha
  • Astrocytoma
  • Glioblastoma
  • Glioma
  • Oligodendroglioma

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