NCT00430911

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2007

Completed
Last Updated

February 2, 2007

Status Verified

January 1, 2007

First QC Date

January 31, 2007

Last Update Submit

January 31, 2007

Conditions

Primary Brain TumorAnaplastic AstrocytomaGlioblastoma Multiforme

Keywords

malignant gliomas

Outcome Measures

Primary Outcomes (1)

  • Survival

Secondary Outcomes (3)

  • Progression free survival

  • Quality of life

  • Cognitive functions

Interventions

RadiotherapyDRUG

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Brain radiotherapy
  • Chemotherapy
  • Severe systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de la Salpêtrière

Paris, Île-de-France Region, 75013, France

Location

Related Publications (1)

  • 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. doi: 10.1056/NEJMoa065901.

    PMID: 17429084DERIVED

MeSH Terms

Conditions

Brain NeoplasmsAstrocytomaGlioblastomaGlioma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • jean-yves Delattre, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • Florence Keime-Guibert, MD

    Assitance Publique-Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 31, 2007

First Posted

February 2, 2007

Study Start

February 1, 2001

Last Updated

February 2, 2007

Record last verified: 2007-01

Locations

FR(1)