Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-02-26 @ 7:29 AM
Study NCT ID:
NCT02507518
Status:
UNKNOWN
Last Update Posted:
2018-07-23
First Post:
2015-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of PET Scan in the Evaluation of Early Response to Maintenance Treatment in Advanced Non-small-cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-20', 'studyFirstSubmitDate': '2015-07-21', 'studyFirstSubmitQcDate': '2015-07-22', 'lastUpdatePostDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': '16 weeks after the start of maintenance therapy', 'description': 'time between the start of maintenance therapy and progression'}], 'secondaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': 'on year', 'description': 'time between the start of maintenance therapy and progression or death'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lung cancer, PET, progression free survival'], 'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Non small cell lung cancer is the first cause of cancer related death in France and is becoming an increasing health problem in developing countries.\n\nRecently for patient with no progression disease after first line chemotherapy, new therapies were validated in maintenance (bevacizumab) or switch maintenance treatment (erlotinib, pemetrexed) with improved survival.\n\nUntil now, determination of efficiency of treatment is only based on morphological response (RECIST) and remains inappropriate to such cytostatic drugs for which there is no anatomical lesion modification.\n\nNuclear Medicine and especially 18-FDG Positron Emission Tomography (PET) offers a biologically relevant tool for assessment of tumour response therapies.\n\nThe assumption of the study is that FDG PET would allow to earlier detect a lack of response, thereafter, to modify an ineffective treatment. Indeed, nowadays the treatment is maintained up to evidence of progression disease.\n\nHowever, despite the increasing use of FDG PET for predicting therapeutic response, there are no validated criteria for judging response of maintenance therapy in non-small cell lung cancer.\n\nIt seems necessary to determine standardized criteria response, earlier during the course of maintenance therapy in patient with non small cell lung cancer.\n\nThe final aim is to optimize survival by an adapted metabolic imaging guided therapy.', 'detailedDescription': 'The purpose of the study is to optimize survival by an adapted metabolic imaging therapy in patients with advances non-small cell lung cancer.\n\nThe primary objective of the study is to evaluate the role of SUV and metabolic volume measured by FDG PETScan in the early prediction of treatment response.\n\n80 patients will be included in 2 years. They will be follow up for one year for monitoring the progression free survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age superior to 18 years old\n* Effective contraception method or negative pregnancy test at the inclusion\n* OMS inferior or equal to 1\n* Non-small cell lung cancer stage IIIb or IV\n* Non progressive disease after at lest 4 cycles of platinum-based chemotherapy\n* Eligible fo maintenance therapy with bevacizumab and/or pemetrexed\n* Inform consent signed\n\nExclusion Criteria:\n\n* Evolution of a second cancer in the 3 years before inclusion\n* Pregnancy or breast-feeding\n* poorly controlled diabetes\n* curatorship or guardianship\n* contraindication to iodinated contrast agents\n* participation to another clinical research with an experimental drug\n* impossible decubitus\n* not possibility to follow-up the procedures of the study due to geographic, social or psychic reasons'}, 'identificationModule': {'nctId': 'NCT02507518', 'acronym': 'CALMETTE', 'briefTitle': 'Role of PET Scan in the Evaluation of Early Response to Maintenance Treatment in Advanced Non-small-cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Centre Henri Becquerel'}, 'officialTitle': 'Role of 18FDG PET in the Evaluation of Early Response to Maintenance Treatment With Bevacizumab or Pemetrexed in Advanced Non-small-cell Lung Cancer', 'orgStudyIdInfo': {'id': 'CHB12.01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Two Pet scan Imaging will be done : 14 days before and 16 days after the beginning of maintenance therapy', 'interventionNames': ['Procedure: PET scan imaging']}], 'interventions': [{'name': 'PET scan imaging', 'type': 'PROCEDURE', 'description': 'a PET scan will be done 2 weeks before the start of maintenance therapy and another 16 days after to predict the earlier response to treatment', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76230', 'city': 'Bois-Guillaume', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dominique Paillotin, MD', 'role': 'CONTACT', 'email': 'dominique.paillotin@chu-rouen.fr', 'phone': '+33232889083'}], 'facility': 'CHU Rouen-Hôpital Bois-Guillaume', 'geoPoint': {'lat': 49.4602, 'lon': 1.12219}}, {'zip': '76200', 'city': 'Dieppe', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julie Tillon, MD', 'role': 'CONTACT', 'email': 'julie.tillon@chu-rouen.fr', 'phone': '+33232888031'}], 'facility': 'CH Dieppe', 'geoPoint': {'lat': 49.9216, 'lon': 1.07772}}, {'zip': '76500', 'city': 'Elbeuf', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre-Alexandre Hauss, MD', 'role': 'CONTACT', 'email': 'pierre-alexandre.hauss@chi-elbeuf-louviers.fr', 'phone': '02 32 82 21 45'}], 'facility': 'Centre hospitalier intercommunal Elbeuf Louviers', 'geoPoint': {'lat': 49.28669, 'lon': 1.00288}}, {'zip': '76000', 'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stephanie Becker, MD', 'role': 'CONTACT', 'email': 'stephanie.becker@chb.unicancer.fr', 'phone': '+33232082258'}], 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '76000', 'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Suzanna Bota, MD', 'role': 'CONTACT', 'email': 'suzanna.bota@chu-rouen.fr', 'phone': '+33232888287'}], 'facility': 'CHU Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'centralContacts': [{'name': 'Stéphanie Becker, MD', 'role': 'CONTACT', 'email': 'stephanie.becker@chb.unicancer.fr', 'phone': '+33232082258'}, {'name': 'Olivier Rastelli', 'role': 'CONTACT', 'email': 'olivier.rastelli@chb.unicancer.fr', 'phone': '+33232082900'}], 'overallOfficials': [{'name': 'Stéphanie Becker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Henri Becquerel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Henri Becquerel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}