Radiotherapy for Malignant Astrocytomas in the Elderly - Full Text View

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

MedlinePlus related topics:

Brain Cancer Cancer

U.S. FDA Resources

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

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

Publications indexed to this study:

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
First Received:	January 31, 2007
Last Updated:	January 31, 2007
ClinicalTrials.gov Identifier:	NCT00430911
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

malignant gliomas

Study placed in the following topic categories:

Glioblastoma

Malignant astrocytoma

Astrocytoma

Central Nervous System Diseases

Central Nervous System Neoplasms

Brain Diseases

Brain Neoplasms

Neuroectodermal Tumors

Glioblastoma multiforme

Neoplasms, Germ Cell and Embryonal

Neuroepithelioma

Glioma

Nervous System Neoplasms

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

Nervous System Diseases

Neoplasms, Nerve Tissue

Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on November 20, 2008

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