Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-01-04 @ 2:53 AM
Study NCT ID:
NCT02024035
Status:
COMPLETED
Last Update Posted:
2013-12-31
First Post:
2011-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protocole Advanced RadioTherapy ORL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-23', 'studyFirstSubmitDate': '2011-08-16', 'studyFirstSubmitQcDate': '2013-12-23', 'lastUpdatePostDateStruct': {'date': '2013-12-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The various of cost between tomotherapy and Intensity Modulation Radiation Therapy (IMRT)', 'timeFrame': '18 months', 'description': 'The purpose of this study is to realise a Health economic evaluation of the various cost between tomotherapy and Intensity Modulation Radiation Therapy (IMRT)'}], 'secondaryOutcomes': [{'measure': 'The economic impact of the learning curve of the tomotherapy process, the operating procedures and the activity of the centres', 'timeFrame': '18 months', 'description': 'To estimate the economic impact of the learning curve of the tomotherapy process, the operating procedures and the activity of the centres'}, {'measure': 'To determine the difference of cost for the preparation phase and the irradiation phase of the radiotherapy procedure', 'timeFrame': '18 months', 'description': 'One of the secondary objectives for the economic evaluation is to individualize the difference of cost for the preparation phase and the irradiation phase of the radiotherapy procedure'}, {'measure': 'The salivary toxicity', 'timeFrame': 'at 6; 12 and 18 months post treatment', 'description': 'The salivary function will be assessed at baeline; 6; 12 and 18 months post treatment.\n\nThis evaluation will be done with differents scale (RTOG, EVA); and with salivary scan.'}, {'measure': 'To determine the rate of disease local control', 'timeFrame': 'Baseline, Month 6; Month 18', 'description': 'Assement of disease by clinical exam and/or imaging.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tomotherapy', 'Head and neck squamous celle carcinoma', 'Health economic evaluation'], 'conditions': ['Head and Neck Squamous Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '28864403', 'type': 'DERIVED', 'citation': 'Bibault JE, Dussart S, Pommier P, Morelle M, Huguet M, Boisselier P, Coche-Dequeant B, Alfonsi M, Bardet E, Rives M, Calugaru V, Chajon E, Noel G, Mecellem H, Servagi Vernat S, Perrier L, Giraud P. Clinical Outcomes of Several IMRT Techniques for Patients With Head and Neck Cancer: A Propensity Score-Weighted Analysis. Int J Radiat Oncol Biol Phys. 2017 Nov 15;99(4):929-937. doi: 10.1016/j.ijrobp.2017.06.2456. Epub 2017 Jun 27.'}, {'pmid': '27345843', 'type': 'DERIVED', 'citation': 'Bibault JE, Morelle M, Perrier L, Pommier P, Boisselier P, Coche-Dequeant B, Gallocher O, Alfonsi M, Bardet E, Rives M, Calugaru V, Chajon E, Noel G, Mecellem H, Perol D, Dussart S, Giraud P. Toxicity and efficacy of cetuximab associated with several modalities of IMRT for locally advanced head and neck cancer. Cancer Radiother. 2016 Jul;20(5):357-61. doi: 10.1016/j.canrad.2016.05.009. Epub 2016 Jun 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to do health economic evaluation of tomotherapy and dynamic arctherapy (2 techniques exist: RapidArc and Vmat).\n\nThis study evaluate also local disease control after 18 months in patients with an ENT epidermoid carcinoma and treated by tomotherapy orarctherapy .\n\nThe number of patients required in this study is: 300:\n\n* Number of patients treated with tomotherapy: 120\n* Number of patients treated with dynamic arctherapy RapidArc: 120\n* Number of patients treated with dynamic arctherapy Vmat: 60\n\nThis is a prospective; multicentric and non randomized study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with Cavum Epidermoïd or undifferentiated carcinoma; or oropharynx epidermoïd carcinoma; or oral cavity epidermoïd carcinoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PS \\<= 2\n* Age \\>= 18 years\n* Histologically proven carcinoma\n* Cavum Epidermoïd or undifferentiated carcinoma; or oropharynx epidermoïd carcinoma; or oral cavity epidermoïd carcinoma\n* Stade T1 to T4\n* M0\n* Patient with no surgery ( except laser partial surgery and ganglionic cleaning out)\n* Bilateral ganlionic cervical area irradiation\n* Covered by a medical insurance.\n\nExclusion Criteria:\n\n* Prior history of other malignancies in the last 5 years(except non evolutive ENT cancer or squamous cell carcinoma )\n* Re-irradiation indication\n* Unilateral cervical area irradiation\n* Post-operative radiotherapy\n* Patient treated by amifostine\n* Impossible follow-up'}, 'identificationModule': {'nctId': 'NCT02024035', 'acronym': 'ART-ORL', 'briefTitle': 'Protocole Advanced RadioTherapy ORL', 'organization': {'class': 'OTHER', 'fullName': 'Centre Leon Berard'}, 'officialTitle': 'Health Economic Evaluation of Tomotherapy and Dynamic Arctherapy in ENT Epidermoid Carcinoma', 'orgStudyIdInfo': {'id': 'ART-ORL'}, 'secondaryIdInfos': [{'id': 'ET 2009-044'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tomotherapy', 'interventionNames': ['Radiation: Radiotherapy']}, {'label': "Arc'therapy Vmat", 'interventionNames': ['Radiation: Radiotherapy']}, {'label': "Arctherapy Rapid'Arc", 'interventionNames': ['Radiation: Radiotherapy']}], 'interventions': [{'name': 'Radiotherapy', 'type': 'RADIATION', 'armGroupLabels': ["Arc'therapy Vmat", "Arctherapy Rapid'Arc", 'Tomotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84000', 'city': 'Avignon', 'country': 'France', 'facility': 'Institut Sainte Catherine', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut BERGONIE', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '5900', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69008', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '57072', 'city': 'Metz', 'country': 'France', 'facility': 'Centre Privé de Radiothérapie de Metz', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': "Centre Val d'Aurelle", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '54511', 'city': 'Nancy', 'country': 'France', 'facility': 'Centre Alexis Vautrin', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '75005', 'city': 'Paris', 'country': 'France', 'facility': 'Intitut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Eurppéen Geoges POMPIDOU', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35042', 'city': 'Rennes', 'country': 'France', 'facility': 'Centre Eugène Marquis', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '44800', 'city': 'Saint-Herblain', 'country': 'France', 'facility': 'Centre René GAUDUCHEAU', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '67085', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Centre Paul STRAUSS', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31300', 'city': 'Toulouse', 'country': 'France', 'facility': 'Groupe Oncorad Garonne', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31400', 'city': 'Toulouse', 'country': 'France', 'facility': 'Institut Claudius Regaud', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Philippe GIRAUD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Europeen Georges Pompidou, Paris; FRANCE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Leon Berard', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Biostatistics and Therapy Evaluation Unit', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}