Clinical trial · Interventional
Impact of Surgery on the Treatment of Supratentorial Malignant Gliomas in Subjects Aged 70 and Over
NCT02892708CI-TRIAL-00055457CSAcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Glioma | Malignant Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiotherapy | Radiation | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Surgery
- description
- Surgical resection followed by radiation therapy
- interventionNames
- Procedure: Surgery
- type
- EXPERIMENTAL
- label
- radiotherapy alone
- description
- radiotherapy after a brain biopsy
- interventionNames
- Radiation: radiotherapy
Primary outcomes (1)
- measure
- duration of survival
- timeFrame
- From date of randomization until the date of death from any cause, assessed up to 100 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDLaigle-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 36242578