NCT02892708

Impact of Surgery on the Treatment of Supratentorial Malignant Gliomas in Subjects Aged 70 and Over

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Currently, the standard treatment for gliomas is based on surgical resection followed by radiation therapy. 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

• Malignant Glioma

Interventions

Type	Name	Description
PROCEDURE	Surgery	partial or complete resection followed by radiotherapy
RADIATION	radiotherapy	radiotherapy after a brain biopsy

Timeline

• Start date: 2008-04-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2016-09-08
• Last updated: 2021-12-09

Locations

1 site across 1 country: France