Status:
COMPLETED
Randomized Phase III Study of Sequential Radiochemotherapy of Anaplastic Glioma With PCV or Temozolomide
Lead Sponsor:
Neuro-Oncology Working Group of the German Cancer Society
Collaborating Sponsors:
University Hospital Tuebingen
Heinrich-Heine University, Duesseldorf
Conditions:
Anaplastic Astrocytoma
Oligodendroglioma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
318 Patients enrolled
Trial Details
Trial ID
NCT00717210
Start Date
June 1 1999
End Date
March 1 2008
Last Update
July 17 2008
Active Locations (12)
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1
University of Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
2
Neurology and Radiotherapy
Tübingen, Baden-Wurttemberg, Germany, 72076
3
Klinikum Aschaffenburg
Aschaffenburg, Germany
4
Nervenklinik
Bamberg, Germany