Randomized Phase III Study of Sequential Radiochemotherapy of Anaplastic Glioma With PCV or Temozolomide
Status:
Completed
Trial end date:
2008-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Neuro-Oncology Working Group of the German Cancer Society
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