Radiotherapy for Malignant Astrocytomas in the Elderly

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00430911
First received: January 31, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted

January 31, 2007
January 31, 2007
February 2001
Not Provided
Survival
Same as current
No Changes Posted
  • Progression free survival
  • Quality of life
  • Cognitive functions
Same as current
Not Provided
Not Provided
 
Radiotherapy for Malignant Astrocytomas in the Elderly
Not Provided

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Primary Brain Tumor
  • Anaplastic Astrocytoma
  • Glioblastoma Multiforme
Drug: Radiotherapy
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00430911
PHRC, P000502 AOM 98071
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: jean-yves Delattre, MD Assistance Publique - Hôpitaux de Paris
Principal Investigator: Florence Keime-Guibert, MD Assitance Publique-Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP