Ignite Creation Date:
2024-05-05 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 9:52 AM
Study NCT ID:
NCT00717210
Status:
COMPLETED
Last Update Posted:
2008-07-17
First Post:
2008-07-15
Brief Title:
Randomized Phase III Study of Sequential Radiochemotherapy of Anaplastic Glioma With PCV or Temozolomide
Sponsor:
Neuro-Oncology Working Group of the German Cancer Society
Organization:
Neuro-Oncology Working Group of the German Cancer Society
Study Overview
Official Title:
NOA-04 Randomized Phase III Study of Sequential Radiochemotherapy of Anaplastic Glioma With PCV or Temozolomide
Status:
COMPLETED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NOA-04
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 211 between June 1999 and February 2005 in 34 German centers to receive i a 6-week course of radiotherapy 18-2 Gy fractions total dose 54-60 Gy or ii four 6-week cycles of CCNU at 110 mg mgm2 on day 1 vincristine at 2 mg on days 8 and 29 and procarbazine at 60 mgm2 on days 8-21 or eight 4-week cycles of 200 mgm2 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 11 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 005
Methods Pts were randomized 211 between June 1999 and February 2005 in 34 German centers to receive i a 6-week course of radiotherapy 18-2 Gy fractions total dose 54-60 Gy or ii four 6-week cycles of CCNU at 110 mg mgm2 on day 1 vincristine at 2 mg on days 8 and 29 and procarbazine at 60 mgm2 on days 8-21 or eight 4-week cycles of 200 mgm2 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 11 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 005
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None