Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT05025618
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2021-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma (ARTOME)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009959', 'term': 'Oropharyngeal Neoplasms'}, {'id': 'D014987', 'term': 'Xerostomia'}], 'ancestors': [{'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-30', 'studyFirstSubmitDate': '2021-08-24', 'studyFirstSubmitQcDate': '2021-08-24', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cost utility analysis of standard radiotherapy (one pretherapeutic planification) compared to adaptative (weekly planification)', 'timeFrame': '2 years after end of radiotherapy treatment', 'description': 'The cost utility analysis is expressed in cost per one year life gained'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adaptative radiotherapy', 'xerostomia', 'medico-economic assessment'], 'conditions': ['Oropharynx Cancer']}, 'descriptionModule': {'briefSummary': 'Standard treatment for oropharynx cancer is radiotherapy by intensity modulation with only one planification before treatment. Adaptative radiotherapy integrates one or several planifications during treatment radiotherapy in order to take into account anatomic modifications that occurs.\n\nAdaptative radiotherapy is very expensive, complex and is consuming human resources as well as equipment.\n\nARTIX study (NCT01874587) entitled "Phase III trial testing the benefit of intensity-modulated radiotherapy with weekly replanifications versus intensity modulated radiotherapy with only one planification in locally advanced oropharynx carcinoma for decreasing xerostomia" is completed and clinical data from this study are used to analyse if xerostomia is decreased when adaptative radiotherapy is used.\n\nARTOME study will assess cost-efficiency and cost utility between standard treatment (one pretherapeutic planification) and experimental treatment (weekly replanifications during treatment). Clinical data from ARTIX study will be used for ARTOME study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated for oropharynx cancer in specialized hospitals', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Locally advanced non-metastatic carcinoma of the oropharynx limited to T3 and T4 (whatever the N) and N2-N3 (whatever the T)(AJCC stage III-IV)\n* Age ≥ 18 years and ≤ 75 years\n* Performance status (WHO ≤ 2)\n* Renal, hepatic and cardiovascular functions allowing systemic treatment administration\n* Adapted stomatologic care\n* Signed informed consent form\n* Membership or beneficiary of a national insurance scheme\n\nExclusion Criteria:\n\n* Both parotids totally included in the target volume\n* Stages T1 or T2 with positive node disease N1\n* Neoadjuvant chemotherapy\n* Exereses of primitive tumor and/or nodes\n* History of other cancer within 5 years (except for basocellular epithelioma and cervical)\n* Previous neck radiotherapy\n* Platinum salts, 5FluoroUracile (5FU) agents or cetuximab chemotherapy\n* Unstable diseases (cardiovascular, renal, pulmonary, systemic lupus or sclerodermia) incompatible with study participation\n* Patient participating in other therapeutic trial with experimental drug, 30 days before the inclusion.\n* Patient already recruited in another biomedical research ( non interventional study is authorized)\n* Pregnant or breast feeding patients\n* Patient deprived of liberty, under tutorship, guardianship or placed under judicial protection\n* Patient is deemed incapable of giving informed consent\n* Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls.'}, 'identificationModule': {'nctId': 'NCT05025618', 'acronym': 'ARTOME', 'briefTitle': 'Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma (ARTOME)', 'organization': {'class': 'OTHER', 'fullName': 'Center Eugene Marquis'}, 'officialTitle': 'Medico-economic Assessment of Adaptative Radiotherapy to Decrease Xerostomia in Locally Advanced Oropharynx Xerostomia', 'orgStudyIdInfo': {'id': '2015-7-10-002'}}, 'contactsLocationsModule': {'locations': [{'city': 'Albi', 'country': 'France', 'facility': 'Clinique Claude Bernard', 'geoPoint': {'lat': 43.9298, 'lon': 2.148}}, {'city': 'Brest', 'country': 'France', 'facility': 'Clinique Pasteur Lanroze', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '14076', 'city': 'Caen', 'country': 'France', 'facility': 'CRLCC Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'CRLCC Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '06189', 'city': 'Nice', 'country': 'France', 'facility': 'CRLCC Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU de la Milétrie', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '35042', 'city': 'Rennes', 'country': 'France', 'facility': 'Centre Eugene Marquis', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rouen', 'country': 'France', 'facility': 'CRLCC Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'Centre Paul Strauss', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Tours', 'country': 'France', 'facility': 'CHU Tours - Hôpital Bretonneau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Renaud De Crevoisier, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Eugène Marquis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center Eugene Marquis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}