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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 70 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02892708
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Assistance Publique - Hôpitaux de Paris
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Philippe Cornu
Principal Investigator Affiliation Assistance Publique - Hôpitaux de Paris
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Malignant Glioma
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Surgery

Surgical resection followed by radiation therapy

Experimental: radiotherapy alone

radiotherapy after a brain biopsy

Interventions

Procedure: - Surgery

partial or complete resection followed by radiotherapy

Radiation: - radiotherapy

radiotherapy after a brain biopsy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Florence Laigle, Paris, France

Status

Address

Florence Laigle

Paris, , 75013

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