Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-03-05 @ 5:41 AM
Study NCT ID:
NCT02892708
Status:
COMPLETED
Last Update Posted:
2021-12-09
First Post:
2016-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Surgery on the Treatment of Supratentorial Malignant Gliomas in Subjects Aged 70 and Over
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-26', 'studyFirstSubmitDate': '2016-05-17', 'studyFirstSubmitQcDate': '2016-09-01', 'lastUpdatePostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'duration of survival', 'timeFrame': 'From date of randomization until the date of death from any cause, assessed up to 100 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['supratentorial gliomas', 'surgery', 'magnetic resonance spectroscopy', 'elderly'], 'conditions': ['Malignant Glioma']}, 'referencesModule': {'references': [{'pmid': '36242578', 'type': 'DERIVED', '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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Currently, the standard treatment for gliomas is based on surgical resection followed by radiation therapy.\n\nHowever 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.\n\nThe 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.\n\nIn 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.\n\nA central review blades and MRI data will be organized after the inclusion of patients.\n\nA maximum of 135 patients will participate in this trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Highly suggestive radiological aspect of a high-grade glioma\n* 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\n* Age greater than or equal to 70 years\n* Preoperative Karnofsky Index ≥ 50\n* Information given to the patient or his family and signed written consent.\n\nExclusion Criteria:\n\n* Existence of a cons-indication to MRI\n* Non operability of the lesion\n* Unbalanced concomitant serious pathology that might be an indication against-formal anesthetic (ASA 4-5) (see annex)\n* Previous history of radiotherapy or chemotherapy prior to this injury\n* Patient under guardianship or under judicial protection'}, 'identificationModule': {'nctId': 'NCT02892708', 'acronym': 'CSA', 'briefTitle': 'Impact of Surgery on the Treatment of Supratentorial Malignant Gliomas in Subjects Aged 70 and Over', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Impact of Surgery on the Treatment of Supratentorial Malignant Gliomas in Subjects Aged 70 and Over', 'orgStudyIdInfo': {'id': 'K060215'}, 'secondaryIdInfos': [{'id': 'ID RCB : 2007-A00522-51', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Surgery', 'description': 'Surgical resection followed by radiation therapy', 'interventionNames': ['Procedure: Surgery']}, {'type': 'EXPERIMENTAL', 'label': 'radiotherapy alone', 'description': 'radiotherapy after a brain biopsy', 'interventionNames': ['Radiation: radiotherapy']}], 'interventions': [{'name': 'Surgery', 'type': 'PROCEDURE', 'description': 'partial or complete resection followed by radiotherapy', 'armGroupLabels': ['Surgery']}, {'name': 'radiotherapy', 'type': 'RADIATION', 'description': 'radiotherapy after a brain biopsy', 'armGroupLabels': ['radiotherapy alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Florence Laigle', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Philippe Cornu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}