Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT00934505
Status:
UNKNOWN
Last Update Posted:
2012-05-25
First Post:
2009-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictive Value of Pet Scan With Fdg Performed During Irradiation in Patients Treated for Oesaphagus Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-24', 'studyFirstSubmitDate': '2009-07-07', 'studyFirstSubmitQcDate': '2009-07-07', 'lastUpdatePostDateStruct': {'date': '2012-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Positron-Emission Tomography', 'PET Scan', 'FDG', 'oesophageal cancer', 'chemo-Radiation Oncology', 'SUV'], 'conditions': ['Oesophageal Cancer']}, 'referencesModule': {'references': [{'pmid': '25417733', 'type': 'DERIVED', 'citation': 'Nkhali L, Thureau S, Edet-Sanson A, Doyeux K, Benyoucef A, Gardin I, Michel P, Vera P, Dubray B. FDG-PET/CT during concomitant chemo radiotherapy for esophageal cancer: Reducing target volumes to deliver higher radiotherapy doses. Acta Oncol. 2015 Jun;54(6):909-15. doi: 10.3109/0284186X.2014.973062. Epub 2014 Nov 24.'}, {'pmid': '23715903', 'type': 'DERIVED', 'citation': "Palie O, Michel P, Menard JF, Rousseau C, Rio E, Bridji B, Benyoucef A, Meyer ME, Jalali K, Bardet S, M'vondo CM, Olivier P, Faure G, Itti E, Diana C, Houzard C, Mornex F, Di Fiore F, Vera P. The predictive value of treatment response using FDG PET performed on day 21 of chemoradiotherapy in patients with oesophageal squamous cell carcinoma. A prospective, multicentre study (RTEP3). Eur J Nucl Med Mol Imaging. 2013 Sep;40(9):1345-55. doi: 10.1007/s00259-013-2450-7. Epub 2013 May 29."}]}, 'descriptionModule': {'briefSummary': 'The poor prognosis in the early-stage of oesophageal carcinoma cancer is due to potential worsening of the disease (local relapse, metastasis), to insufficient efficacy and toxicity of actual treatments.\n\nFDG-PET is a medical imaging modality allowing the quantification of the tumour glucose consumption. Then, this exam is used for pathology staging, target volume definition for RT, and treatment efficiency few months after CRT. Our assumption is that an FDG-PET exam during the course of CRT might be predictive of the treatment efficiency few months later.\n\nIn this study, we propose to perform 4 FDG-PET: first "PET1" before chemo-radiotherapy, second "PET2" during the chemo-radiotherapy (see RTEP1), third and fourth "PET3" "PET4" 3month and 12 month after the end of radiotherapy.\n\nWe will investigate the performances of FDG-PET performed during CRT for the prediction of the one-year patient heath outcome. If the predictive value of TEP2 is confirmed, we would be able to optimize the planning treatment during the course of the therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Diagnosed patients a carcinoma of the oesophagus histologiquement proved', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Carcinoma épidermoïde of the oesophagus histologically proved, UICC Stage II B, III or IVa (TNM on 2002)\n* Decision of treatment by radio concomitant chemotherapy (radiotherapy in classic spreading of 50Gy associated with a platinum chemotherapy.\n\nExclusion Criteria:\n\n* Presence of a second evolutionary cancer in the previous three years\n* index of performance OMS \\> 2\n* Patients badly balanced diabetics'}, 'identificationModule': {'nctId': 'NCT00934505', 'acronym': 'RTEP3', 'briefTitle': 'Predictive Value of Pet Scan With Fdg Performed During Irradiation in Patients Treated for Oesaphagus Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Centre Henri Becquerel'}, 'officialTitle': 'Predictive Value of FDG-TEP During Exclusive Chemo-Radiotherapy (CRT) in Patients With Oesophageal Carcinoma Cancer on the One-Year Survival (RTEP3)', 'orgStudyIdInfo': {'id': 'CHB08-02'}}, 'contactsLocationsModule': {'locations': [{'zip': '76000', 'city': 'Rouen', 'state': 'Haute Normandie', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'THILLAYS Marc, RT', 'role': 'CONTACT', 'email': 'marc.thillays@touen.fnclcc.fr', 'phone': '0033232082497'}, {'name': 'GOUEL Pierrick, RT', 'role': 'CONTACT', 'email': 'pierrick.gouel@rouen.fnclcc.fr', 'phone': '0033232082497'}, {'name': 'BENYOUCEF Ahmed, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CLCC H.Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'centralContacts': [{'name': 'THILLAYS Marc, RCA', 'role': 'CONTACT', 'email': 'marc.thillays@rouen.fnclcc.fr', 'phone': '00330232082497'}], 'overallOfficials': [{'name': 'VERA Pierre, MD phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHBecquerel'}, {'name': 'MICHEL Pierre, MD phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU Rouen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Henri Becquerel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}