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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00717210
Recruitment Status : Completed
First Posted : July 17, 2008
Last Update Posted : July 17, 2008
Sponsor:
Collaborators:
University Hospital Tuebingen
Heinrich-Heine University, Duesseldorf
Heidelberg University
Charite University, Berlin, Germany
University Hospital, Essen
University of Leipzig
University Hospital, Bonn
German Cancer Research Center
University of Zurich
Information provided by:
Neuro-Oncology Working Group of the German Cancer Society

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Anaplastic Astrocytoma Oligodendroglioma Oligoastrocytoma Drug: Temozolomide Radiation: Focal radiotherapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 318 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NOA-04 Randomized Phase III Study of Sequential Radiochemotherapy of Anaplastic Glioma With PCV or Temozolomide
Study Start Date : June 1999
Actual Primary Completion Date : February 2005
Actual Study Completion Date : March 2008


Arm Intervention/treatment
Active Comparator: A
Conventional Radiotherapy
Radiation: Focal radiotherapy
54-60 Gy in 28-30 fractions over 6-7 weeks

Experimental: B1/2
1:1 randomization between temozolomide and procarbazine/lomustine/vincristine (PCV)
Drug: Temozolomide
200 mg/m2 body surface on days 1-5 every 28 days for 8 cycles; and again for another 4 cycles at primary progression




Primary Outcome Measures :
  1. Time-to-treatment-failure defined as progression after radiotherapy and one chemotherapy in either sequence [ Time Frame: 1999-2008 ]

Secondary Outcome Measures :
  1. Progression-free survival Overall Survival Toxicity Response rates [ Time Frame: 1999-2012 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717210


Locations
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Germany
University of Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69120
Neurology and Radiotherapy
Tübingen, Baden-Württemberg, Germany, 72076
Klinikum Aschaffenburg
Aschaffenburg, Germany
Nervenklinik
Bamberg, Germany
Charite
Berlin, Germany
Neurosurgery
Düsseldorf, Germany
Radiotherapy
Erlangen, Germany
Neurology
Essen, Germany
Neurosurgery
Frankfurt, Germany
Neurosurgery
Kiel, Germany
Neurosurgery
Mainz, Germany
County District Hospital
Regensburg, Germany
Sponsors and Collaborators
Neuro-Oncology Working Group of the German Cancer Society
University Hospital Tuebingen
Heinrich-Heine University, Duesseldorf
Heidelberg University
Charite University, Berlin, Germany
University Hospital, Essen
University of Leipzig
University Hospital, Bonn
German Cancer Research Center
University of Zurich
Investigators
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Principal Investigator: Michael Weller, MD Department of Neurology, University of Zurich, Switzerland
Study Director: Wolfgang Wick, MD Department of Neurooncology, University of Heidelberg

Additional Information:
Publications of Results:
Wick W, Weller M for the Neurooncology Working Group (NOA) of the German Cancer Society Randomized phase -III study of sequential radiochemotherapy of oligoastrocytic tumors of WHO-grade III with PCV or temozolomide: NOA-04. J Clin Oncol 2008;26(15S):2007.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dr. Michael Weller, NOA
ClinicalTrials.gov Identifier: NCT00717210    
Other Study ID Numbers: NOA-04
First Posted: July 17, 2008    Key Record Dates
Last Update Posted: July 17, 2008
Last Verified: July 2008
Keywords provided by Neuro-Oncology Working Group of the German Cancer Society:
1p/19q loss
MGMT
prognostic factors
PCV
temozolomide
Additional relevant MeSH terms:
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Astrocytoma
Oligodendroglioma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents