Impact of Surgery on the Treatment of Supratentorial Malignant Gliomas in Subjects Aged 70 and Over
CSA
2 other identifiers
interventional
107
1 country
1
Brief Summary
The objective of this study is to evaluate the efficacy and safety of surgical resection in elderly patients 70 years or older with a supratentorial glioblastoma de novo. The sensitivity of Magnetic Resonance Spectroscopy with perfusion sequences in the diagnosis of malignant glioma in the elderly will also be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2008
Longer than P75 for phase_3
1 active site
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
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 17, 2016
CompletedFirst Posted
Study publicly available on registry
September 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedDecember 9, 2021
November 1, 2021
10 years
May 17, 2016
November 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
duration of survival
From date of randomization until the date of death from any cause, assessed up to 100 months
Study Arms (2)
Surgery
ACTIVE COMPARATORSurgical resection followed by radiation therapy
radiotherapy alone
EXPERIMENTALradiotherapy after a brain biopsy
Interventions
Eligibility Criteria
You may qualify if:
- Highly suggestive radiological aspect of a high-grade glioma
- Operability of the lesion, defined according to standard criteria of literature: lobar tumor, cortico-subcortical, well limited, without deep infiltration and without involvement of the basal ganglia. This operability is to reassess based on surgical experience and the ability to remove more or less completely a tumor of this type in a given location
- Age greater than or equal to 70 years
- Preoperative Karnofsky Index ≥ 50
- Information given to the patient or his family and signed written consent.
You may not qualify if:
- Existence of a cons-indication to MRI
- Non operability of the lesion
- Unbalanced concomitant serious pathology that might be an indication against-formal anesthetic (ASA 4-5) (see annex)
- Previous history of radiotherapy or chemotherapy prior to this injury
- Patient under guardianship or under judicial protection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Florence Laigle
Paris, 75013, France
Related Publications (1)
Laigle-Donadey F, Metellus P, Guyotat J, Menei P, Proust F, Dufour H, Chinot O, Honnorat J, Faillot T, Paquis P, Peruzzi P, Emery E, Guillamo JS, Carpentier A, Wager M, Lebbah S, Hajage D, Delattre JY, Cornu P. Surgery for glioblastomas in the elderly: an Association des Neuro-oncologues d'Expression Francaise (ANOCEF) trial. J Neurosurg. 2022 Oct 14;138(5):1199-1205. doi: 10.3171/2022.8.JNS221068. Print 2023 May 1.
PMID: 36242578DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philippe Cornu
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2016
First Posted
September 8, 2016
Study Start
April 1, 2008
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
December 9, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share