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

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Glioblastoma Glioma Anaplastic Astrocytoma Neuroepithelioma

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 (Senior)
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

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, see Learn About Clinical Studies.

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

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

Keime-Guibert F, Chinot O, Taillandier L, Cartalat-Carel S, Frenay M, Kantor G, Guillamo JS, Jadaud E, Colin P, Bondiau PY, Meneï P, Loiseau H, Bernier V, Honnorat J, Barrié 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.


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

Keywords provided by Assistance Publique - Hôpitaux de Paris:


malignant gliomas

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 28, 2016

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