Anaplastic Astrocytoma Clinical Trial
Official title:
NOA-04 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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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