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

Last updated: November 26, 2021
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Completed

Phase

3

Condition

Brain Tumor

Glioblastoma Multiforme

Astrocytoma

Treatment

N/A

Clinical Study ID

NCT02892708
K060215
ID RCB : 2007-A00522-51
  • Ages > 70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Highly suggestive radiological aspect of a high-grade glioma
  • Operability of the lesion, defined according to standard criteria of literature: lobartumor, cortico-subcortical, well limited, without deep infiltration and withoutinvolvement of the basal ganglia. This operability is to reassess based on surgicalexperience and the ability to remove more or less completely a tumor of this type in agiven 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

Exclusion Criteria:

  • Existence of a cons-indication to MRI
  • Non operability of the lesion
  • Unbalanced concomitant serious pathology that might be an indication against-formalanesthetic (ASA 4-5) (see annex)
  • Previous history of radiotherapy or chemotherapy prior to this injury
  • Patient under guardianship or under judicial protection

Study Design

Total Participants: 107
Study Start date:
April 01, 2008
Estimated Completion Date:
April 30, 2018

Study 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.

Connect with a study center

  • Florence Laigle

    Paris, 75013
    France

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.