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NCT Number: NCT00717210

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

Background: The optimal treatment of anaplastic gliomas is controversial. Standard of care in most centers is still radiotherapy. This phase III study compared the efficacy and safety of radiotherapy vs chemotherapy in patients (pts) with newly-diagnosed, supratentorial gliomas of WHO grade III.

Methods: Pts were randomized 2:1:1 between June 1999 and February 2005 in 34 German centers to receive (i) a 6-week course of radiotherapy (1,8-2 Gy fractions, total dose 54-60 Gy) or (ii) four 6-week cycles of CCNU at 110 mg mg/m2 on day 1, vincristine at 2 mg on days 8 and 29 and procarbazine at 60 mg/m2 on days 8-21 or eight 4-week cycles of 200 mg/m2 temozolomide on days 1-5. Treatment was stopped prematurely at disease progression or occurrence of unacceptable toxicity. At this time or at disease progression, treatment in the radiotherapy group was continued with one of the chemotherapies (1:1 randomization) and with radiotherapy in both chemotherapy groups. The primary endpoint was time-to-treatment-failure (TTF) defined as progression after radiotherapy and one chemotherapy in either sequence, or any time before if further therapy could not be employed. Assuming a 50% improvement in TTF of starting with chemotherapy, 318 pts were to be enrolled to provide 80% power to achieve statistical significance at a one-sided level of 0.05.

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Key information

Conditions

Anaplastic Astrocytoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Oligoastrocytoma Oligodendroglioma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Heidelberg, Heidelberg, Baden-Wurttemberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Temozolomide

Drug

200 mg/m2 body surface on days 1-5 every 28 days for 8 cycles; and again for another 4 cycles at primary progression

Focal radiotherapy

Radiation

54-60 Gy in 28-30 fractions over 6-7 weeks

Primary outcomes

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

    Time frame: 1999-2008

Secondary outcomes

  1. Progression-free survival Overall Survival Toxicity Response rates

    Time frame: 1999-2012

Sponsors and collaborators

Lead sponsor

Neuro-Oncology Working Group of the German Cancer Society

Network

Collaborators

  • Charite University, Berlin, Germany
  • German Cancer Research Center
  • Heidelberg University
  • Heinrich-Heine University, Duesseldorf
  • University Hospital Tuebingen
  • University Hospital, Bonn
  • University Hospital, Essen
  • University of Leipzig
  • University of Zurich

Registry information

Official study title

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

Acronym: NOA-04

Important dates

Study start
1999
Primary completion
2005
Study completion
2008
First posted
Jul 17, 2008
Registry last updated
Jul 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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