Impact of Surgery on the Treatment of Supratentorial Malignant Gliomas in Subjects Aged 70 and Over
NCT ID: NCT02892708
Last Updated: 2021-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
107 participants
INTERVENTIONAL
2008-04-30
2018-04-30
Brief Summary
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Detailed Description
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However in patients 70 and older, surgery is not systematic, before radiotherapy. Moreover, at these ages, surgery is likely to be less well tolerated in general terms.
The aim of this study is to try to determine the best treatment between radiation therapy associated with the surgical treatment and care by radiotherapy alone, after a brain biopsy. This is a randomized, two arms, multicenter, open study.
In the two weeks following the radiological diagnosis of a lesion highly suggestive of a high-grade glioma, patients will be randomized to either arm surgery (partial or complete excision) + radiotherapy or in the radiotherapy alone arm. Within 5 weeks after surgery (biopsy or excision), all patients will receive treatment with focal radiotherapy.
A central review blades and MRI data will be organized after the inclusion of patients.
A maximum of 135 patients will participate in this trial.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Surgery
Surgical resection followed by radiation therapy
Surgery
partial or complete resection followed by radiotherapy
radiotherapy alone
radiotherapy after a brain biopsy
radiotherapy
radiotherapy after a brain biopsy
Interventions
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Surgery
partial or complete resection followed by radiotherapy
radiotherapy
radiotherapy after a brain biopsy
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
70 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Philippe Cornu
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Florence Laigle
Paris, , France
Countries
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References
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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.
Other Identifiers
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ID RCB : 2007-A00522-51
Identifier Type: OTHER
Identifier Source: secondary_id
K060215
Identifier Type: -
Identifier Source: org_study_id