Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2026-01-02 @ 12:42 AM
Study NCT ID:
NCT00911092
Status:
COMPLETED
Last Update Posted:
2012-01-02
First Post:
2009-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Proteomic Factors of the Response to Concomitant Radiochemotherapy in Esophageal Cancer
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-30', 'studyFirstSubmitDate': '2009-05-29', 'studyFirstSubmitQcDate': '2009-05-29', 'lastUpdatePostDateStruct': {'date': '2012-01-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proteomic analysis by Protein-Chip Technology of Ciphergen and mass spectrometry', 'timeFrame': '15 weeks after the end of irradiation'}, {'measure': 'Initial complete clinical response', 'timeFrame': '15 weeks after the end of irradiation'}], 'secondaryOutcomes': [{'measure': 'Prolonged clinical response at one year', 'timeFrame': 'One year after the end of irradiation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Oesophageal cancer', 'exclusive concomitant radiochemotherapy'], 'conditions': ['Esophageal Cancer']}, 'descriptionModule': {'briefSummary': 'The scope of the trial is to predict the early complete clinical response to exclusive concomitant radiochemotherapy in esophageal cancer by the study of the pre- and per- therapeutic proteomic profile.', 'detailedDescription': 'Further informations will be provided by Centre Oscar Lambret.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Invasive esophageal carcinoma at any stage (all T, N0 or N1, M0 or M1a), histologically proven\n* Treated by exclusive concomitant radiochemotherapy\n* Written informed consent\n\nExclusion Criteria:\n\n* Presence of a second uncontrolled cancer\n* Metastatic carcinoma\n* Metastatic disease, except cervical lymphnodes... (M1a)\n* In situ carcinoma\n* Eso-gastric junction cancer (Siewert II ou III)\n* Inclusion in a clinical trial with an experimental drug during the study and until 15 weeks after the end of radiotherapy)'}, 'identificationModule': {'nctId': 'NCT00911092', 'acronym': 'COL06-13', 'briefTitle': 'Predictive Proteomic Factors of the Response to Concomitant Radiochemotherapy in Esophageal Cancer', 'nctIdAliases': ['NCT00932815'], 'organization': {'class': 'OTHER', 'fullName': 'Centre Oscar Lambret'}, 'officialTitle': 'Study of Predictive Proteomic Factors of the Response to Exclusive Concomitant Radiochemotherapy in Oesophageal Cancer', 'orgStudyIdInfo': {'id': '2006-13'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood sampling', 'type': 'PROCEDURE', 'description': 'Before any study treatment, 14 days after radiotherapy, 15 weeks after radiotherapy'}, {'name': 'Radiation', 'type': 'RADIATION', 'description': 'Week 1 to week 5-6 1.8-2 Gys/fraction, 5 days a week for a total of 5 to 6 weeks'}, {'name': 'Chemotherapy (Fluorouracil and Cisplatin)', 'type': 'DRUG', 'description': 'At weeks 1, 5, 8 and 11\n\n* Day 1 to day 4: Fluorouracil 1 gr/m²/day\n* Day 1 or 2: Cisplatin 75 mg/m²'}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'Centre Paul Papin', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '14046', 'city': 'Caen', 'country': 'France', 'facility': 'Centre François BACLESSE', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '35042', 'city': 'Rennes', 'country': 'France', 'facility': 'Centre Eugène Marquis', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'CHU - Hopital Charles Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'ADENIS Antoine, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Oscar Lambret'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Oscar Lambret', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}