Status:
COMPLETED
Phase III Trial of Primary Radio- or Chemotherapy in Malignant Astrocytoma of the Elderly
Lead Sponsor:
Heidelberg University
Conditions:
Glioblastoma
Anaplastic Astrocytoma
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
The study aims to optimize the treatment of elderly subjects (\> 65) with anaplastic astrocytoma and glioblastoma. Current treatment policies tend to be no more than palliative. There is no consensus ...
Detailed Description
This study is a prospective, randomized Phase III intervention study. Following histological documentation of the diagnosis by biopsy or resection of an anaplastic astrocytoma or glioblastoma, patient...
Eligibility Criteria
Inclusion
- Histologically confirmed supratentorial anaplastic astrocytoma or glioblastoma
- Age \> 65
- Karnofsky performance score \> 60%
- Neutrophilic granulocyte count \> 1500/µl
- Platelet count \> 100 000/µl
- Hemoglobin \> 10 g/dl
- Serum creatinine \< 1.5 times the lab's upper normal limit
- AST or ALT \< 3 times the lab's upper normal limit
- Alkaline phosphatase \< 3 times the lab's upper normal limit
- No previous systemic chemotherapy
- No previous radiotherapy to the brain
- Written consent
Exclusion
- Serious medical or neurological condition with a poor prognosis
- HIV infection
- Second cancer requiring radiotherapy or chemotherapy (contact the study coordinat if necessary)
- Hypersensitivity to temozolomide
- Conditions associated with regular vomiting that might affect oral administration of the drugs
- Psychological, familial, social or geographical circumstances with major implications for compliance with the study visit schedule
- Patient was taking part in other intervention studies within a month of starting this study
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
412 Patients enrolled
Trial Details
Trial ID
NCT01502241
Start Date
January 1 2005
End Date
November 1 2011
Last Update
December 30 2011
Active Locations (23)
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1
University of Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
2
University of Frankfurt
Frankfurt am Main, Hesse, Germany, 60528
3
Charite Berlin
Berlin, Germany
4
University of Bochum
Bochum, Germany