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NOA-04 Randomized Phase III Study of Sequential Radiochemotherapy of Anaplastic Glioma With PCV or Temozolomide


Phase 3
18 Years
N/A
Not Enrolling
Both
Anaplastic Astrocytoma, Oligodendroglioma, Oligoastrocytoma

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Trial Information

NOA-04 Randomized Phase III Study of Sequential Radiochemotherapy of Anaplastic Glioma With PCV or Temozolomide


Inclusion Criteria:



- written informed consent

- centrally confirmed anaplastic glioma according to the WHO-classification 1998/2000

- age ≥ 18 years

- Karnofsky performance status (KPS) of 70 or higher

- no prior systemic chemotherapy or radiation therapy of the brain

- no HIV infection

- adequate bone marrow reserve, liver function, and renal function

- Patients on corticosteroids had to be on a stable or decreasing dosage within the 14
days prior to randomization

Exclusion Criteria:

- Glioblastoma

- infratentorial localization of the tumor

- pregnancy or lactation period

- serious medical or neurological comorbidity

- additional malignancy requiring radio- or chemotherapy

- known hypersensitivity against study drugs

- inability to swallow

- frequent emesis

- psychological. familial, sociological or geographical situations impairing compliance
with F/U examinations

- parallel participation in other studies

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time-to-treatment-failure defined as progression after radiotherapy and one chemotherapy in either sequence

Outcome Time Frame:

1999-2008

Safety Issue:

No

Principal Investigator

Michael Weller, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Neurology, University of Zurich, Switzerland

Authority:

Germany: Ethics Commission

Study ID:

NOA-04

NCT ID:

NCT00717210

Start Date:

June 1999

Completion Date:

March 2008

Related Keywords:

  • Anaplastic Astrocytoma
  • Oligodendroglioma
  • Oligoastrocytoma
  • 1p/19q loss
  • MGMT
  • prognostic factors
  • PCV
  • temozolomide
  • Astrocytoma
  • Oligodendroglioma

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