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

Malignant Glioma Clinical Trial

— CSA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02892708
• Other study ID #: K060215
• Secondary ID: ID RCB : 2007-A0
• Status: Completed
• Phase: Phase 3
• Start date: April 2008
• Est. completion date: April 2018

Study information

• Verified date: November 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Malignant Glioma

Intervention

Procedure:
• Surgery
partial or complete resection followed by radiotherapy

Radiation:
• radiotherapy
radiotherapy after a brain biopsy

Locations

Country	Name	City	State
France	Florence Laigle	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of survival		From date of randomization until the date of death from any cause, assessed up to 100 months