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NCT00430911 Clinical Trial

Radiotherapy for Malignant Astrocytomas in the Elderly

Glioblastoma Multiforme Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00430911
Other study ID # PHRC, P000502 AOM 98071
Secondary ID
Status Completed
Phase Phase 3
First received January 31, 2007
Last updated January 31, 2007
Start date February 2001

Study information
Verified date January 2007
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial Summary

A randomized trial comparing radiotherapy with supportive care in patients aged 70 years or older with newly diagnosed, histologically confirmed anaplastic astrocytoma or glioblastoma, and a Karnofsky performance status > 70.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 70 Years and older
Eligibility Inclusion Criteria:

- Glioblastoma and anaplastic astrocytoma, supratentorial, histologically confirmed

- Brain CT scan or MRI within 28 days before surgery

- Age: 70 years or older

- Karnofsky performance status, 70 or more.

- Life expectancy over 12 weeks

- Informed consent

Exclusion Criteria:

- Brain radiotherapy

- Chemotherapy

- Severe systemic disease

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Radiotherapy

Locations
Country Name City State
France Hôpital de la Salpêtrière Paris Ile de France

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival
Secondary Progression free survival
Secondary Quality of life
Secondary Cognitive functions
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