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

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ClinicalTrials.gov Identifier: NCT02892708
Recruitment Status : Unknown
Verified August 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : September 8, 2016
Last Update Posted : September 8, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Malignant Glioma Procedure: Surgery Radiation: radiotherapy Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Surgery on the Treatment of Supratentorial Malignant Gliomas in Subjects Aged 70 and Over
Study Start Date : April 2008
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Surgery
Surgical resection followed by radiation therapy
Procedure: Surgery
partial or complete resection followed by radiotherapy

Experimental: radiotherapy alone
radiotherapy after a brain biopsy
Radiation: radiotherapy
radiotherapy after a brain biopsy




Primary Outcome Measures :
  1. duration of survival [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 100 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02892708


Contacts
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Contact: Florence Laigle, MD, PH 1 42 16 03 81 ext 0033 florence.laigle-donadey@psl.aphp.fr
Contact: Anne Bissery, MD 1 42 16 24 32 ext 0033 anne.bissery@aphp.fr

Locations
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France
Florence Laigle Recruiting
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Philippe Cornu Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02892708     History of Changes
Other Study ID Numbers: K060215
ID RCB : 2007-A00522-51 ( Other Identifier: ANSM )
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
supratentorial gliomas
surgery
magnetic resonance spectroscopy
elderly
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue