ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Survival

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

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   70 Years and older   (Senior)
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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
France
Hôpital de la Salpêtrière
Paris, Ile de France, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: jean-yves Delattre, MD Assistance Publique - Hôpitaux de Paris
Principal Investigator: Florence Keime-Guibert, MD Assitance Publique-Hôpitaux de Paris
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00430911     History of Changes
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:
Glioblastoma
Astrocytoma
Brain Neoplasms
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