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

Primary Purpose

Malignant Glioma

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Surgery
radiotherapy
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Glioma focused on measuring supratentorial gliomas, surgery, magnetic resonance spectroscopy, elderly

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Florence Laigle

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Surgery

radiotherapy alone

Arm Description

Surgical resection followed by radiation therapy

radiotherapy after a brain biopsy

Outcomes

Primary Outcome Measures

duration of survival

Secondary Outcome Measures

Full Information

First Posted
May 17, 2016
Last Updated
November 26, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02892708
Brief Title
Impact of Surgery on the Treatment of Supratentorial Malignant Gliomas in Subjects Aged 70 and Over
Acronym
CSA
Official Title
Impact of Surgery on the Treatment of Supratentorial Malignant Gliomas in Subjects Aged 70 and Over
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 2008 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Glioma
Keywords
supratentorial gliomas, surgery, magnetic resonance spectroscopy, elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgery
Arm Type
Active Comparator
Arm Description
Surgical resection followed by radiation therapy
Arm Title
radiotherapy alone
Arm Type
Experimental
Arm Description
radiotherapy after a brain biopsy
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
partial or complete resection followed by radiotherapy
Intervention Type
Radiation
Intervention Name(s)
radiotherapy
Intervention Description
radiotherapy after a brain biopsy
Primary Outcome Measure Information:
Title
duration of survival
Time Frame
From date of randomization until the date of death from any cause, assessed up to 100 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Cornu
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florence Laigle
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36242578
Citation
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.
Results Reference
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Impact of Surgery on the Treatment of Supratentorial Malignant Gliomas in Subjects Aged 70 and Over

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