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Radiotherapy for Malignant Astrocytomas in the Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00430911
Recruitment Status : Completed
First Posted : February 2, 2007
Last Update Posted : February 2, 2007
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

Study Description
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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.

Condition or disease Intervention/treatment Phase
Primary Brain Tumor Anaplastic Astrocytoma Glioblastoma Multiforme Drug: Radiotherapy Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2001

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Survival

Secondary Outcome Measures :
  1. Progression free survival
  2. Quality of life
  3. Cognitive functions

Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430911


Locations
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France
Hôpital de la Salpêtrière
Paris, Ile de France, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: jean-yves Delattre, MD Assistance Publique - Hôpitaux de Paris
Principal Investigator: Florence Keime-Guibert, MD Assitance Publique-Hôpitaux de Paris
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00430911    
Other Study ID Numbers: PHRC, P000502 AOM 98071
First Posted: February 2, 2007    Key Record Dates
Last Update Posted: February 2, 2007
Last Verified: January 2007
Keywords provided by Assistance Publique - Hôpitaux de Paris:
malignant gliomas
Additional relevant MeSH terms:
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Glioblastoma
Brain Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases