Radiotherapy for Malignant Astrocytomas in the Elderly

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Completed
• CT.gov ID: NCT00430911
• Collaborator: (none)
• Location: 1

Study Details

Study Description

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

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Feb 1, 2001

Outcome Measures

Primary Outcome Measures

1. Survival []

Secondary Outcome Measures

1. Progression free survival []

2. Quality of life []

3. Cognitive functions []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00430911
• Other Study ID Numbers: PHRC, P000502 AOM 98071
• First Posted: Feb 2, 2007
• Last Update Posted: Feb 2, 2007
• Last Verified: Jan 1, 2007

• Keywords provided by , ,: malignant gliomas
• Additional relevant MeSH terms: Glioblastoma; Brain Neoplasms; Astrocytoma

Study Results

No Results Posted as of Feb 2, 2007