Back to resultsRadiotherapy for Malignant Astrocytomas in the Elderly
Primary Purpose
Primary Brain Tumor, Anaplastic Astrocytoma, Glioblastoma Multiforme
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Primary Brain Tumor focused on measuring malignant gliomas
Eligibility Criteria
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
Sites / Locations
- Hôpital de la Salpêtrière
Outcomes
Primary Outcome Measures
Survival
Secondary Outcome Measures
Progression free survival
Quality of life
Cognitive functions
Full Information
NCT ID
NCT00430911
First Posted
January 31, 2007
Last Updated
January 31, 2007
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00430911
Brief Title
Radiotherapy for Malignant Astrocytomas in the Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Brain Tumor, Anaplastic Astrocytoma, Glioblastoma Multiforme
Keywords
malignant gliomas
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Radiotherapy
Primary Outcome Measure Information:
Title
Survival
Secondary Outcome Measure Information:
Title
Progression free survival
Title
Quality of life
Title
Cognitive functions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jean-yves Delattre, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Florence Keime-Guibert, MD
Organizational Affiliation
Assitance Publique-Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital de la Salpêtrière
City
Paris
State/Province
Ile de France
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
17429084
Citation
Keime-Guibert F, Chinot O, Taillandier L, Cartalat-Carel S, Frenay M, Kantor G, Guillamo JS, Jadaud E, Colin P, Bondiau PY, Menei P, Loiseau H, Bernier V, Honnorat J, Barrie M, Mokhtari K, Mazeron JJ, Bissery A, Delattre JY; Association of French-Speaking Neuro-Oncologists. Radiotherapy for glioblastoma in the elderly. N Engl J Med. 2007 Apr 12;356(15):1527-35. doi: 10.1056/NEJMoa065901.
Results Reference
derived
Learn more about this trial
Radiotherapy for Malignant Astrocytomas in the Elderly
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