Radiotherapy for Malignant Astrocytomas in the Elderly

This study has been completed.

First Received: January 31, 2007 No Changes Posted

Sponsor:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00430911

Purpose

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	Intervention	Phase
Primary Brain Tumor Anaplastic Astrocytoma Glioblastoma Multiforme	Drug: Radiotherapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Survival

Secondary Outcome Measures:

Progression free survival
Quality of life
Cognitive functions

Study Start Date:

February 2001

Eligibility

Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430911

Locations

France, Ile de 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

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	PHRC, P000502 AOM 98071
Study First Received:	January 31, 2007
Last Updated:	January 31, 2007
ClinicalTrials.gov Identifier:	NCT00430911 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

malignant gliomas

Additional relevant MeSH terms:

Glioblastoma
Neoplasms by Histologic Type
Astrocytoma
Nervous System Diseases
Neoplasms, Nerve Tissue
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Brain Neoplasms

Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Glioma
Neoplasms, Neuroepithelial
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 09, 2009