Randomized Phase III Study of Sequential Radiochemotherapy of Anaplastic Glioma With PCV or Temozolomide
NCT ID: NCT00717210
Last Updated: 2008-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
318 participants
INTERVENTIONAL
1999-06-30
2008-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Conventional Radiotherapy
Focal radiotherapy
54-60 Gy in 28-30 fractions over 6-7 weeks
B1/2
1:1 randomization between temozolomide and procarbazine/lomustine/vincristine (PCV)
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
Interventions
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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
Focal radiotherapy
54-60 Gy in 28-30 fractions over 6-7 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital Tuebingen
OTHER
Heinrich-Heine University, Duesseldorf
OTHER
Heidelberg University
OTHER
Charite University, Berlin, Germany
OTHER
University Hospital, Essen
OTHER
University of Leipzig
OTHER
University Hospital, Bonn
OTHER
German Cancer Research Center
OTHER
University of Zurich
OTHER
Neuro-Oncology Working Group of the German Cancer Society
NETWORK
Responsible Party
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NOA
Principal Investigators
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Michael Weller, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Neurology, University of Zurich, Switzerland
Wolfgang Wick, MD
Role: STUDY_DIRECTOR
Department of Neurooncology, University of Heidelberg
Locations
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University of Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Neurology and Radiotherapy
Tübingen, Baden-Wurttemberg, Germany
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
Countries
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References
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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.
Wick W, Roth P, Hartmann C, Hau P, Nakamura M, Stockhammer F, Sabel MC, Wick A, Koeppen S, Ketter R, Vajkoczy P, Eyupoglu I, Kalff R, Pietsch T, Happold C, Galldiks N, Schmidt-Graf F, Bamberg M, Reifenberger G, Platten M, von Deimling A, Meisner C, Wiestler B, Weller M; Neurooncology Working Group (NOA) of the German Cancer Society. Long-term analysis of the NOA-04 randomized phase III trial of sequential radiochemotherapy of anaplastic glioma with PCV or temozolomide. Neuro Oncol. 2016 Nov;18(11):1529-1537. doi: 10.1093/neuonc/now133. Epub 2016 Jul 1.
Other Identifiers
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NOA-04
Identifier Type: -
Identifier Source: org_study_id