Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:24 AM
Study NCT ID:
NCT00697333
Status:
UNKNOWN
Last Update Posted:
2016-07-14
First Post:
2008-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiotherapy Planning Based on Positron Emission Tomography With Fluoro-deoxyglucose For Advanced NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-13', 'studyFirstSubmitDate': '2008-06-11', 'studyFirstSubmitQcDate': '2008-06-12', 'lastUpdatePostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to local progression', 'timeFrame': 'actuarial', 'description': 'Time from randomization to first evidence of local progression or last follow up'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'actuarial', 'description': 'Time from randomization to death or last follow up'}, {'measure': 'normal tissue toxicity', 'timeFrame': 'actuarial', 'description': 'Time from randomization to death or last follow up'}, {'measure': 'in and out field progression', 'timeFrame': 'actuarial', 'description': 'Time from randomization to progression or last follow up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NSCLC', 'FDG-PET', 'Radiotherapy', 'planning', 'target volumes'], 'conditions': ['Non-small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '17064802', 'type': 'BACKGROUND', 'citation': 'Nestle U, Kremp S, Grosu AL. Practical integration of [18F]-FDG-PET and PET-CT in the planning of radiotherapy for non-small cell lung cancer (NSCLC): the technical basis, ICRU-target volumes, problems, perspectives. Radiother Oncol. 2006 Nov;81(2):209-25. doi: 10.1016/j.radonc.2006.09.011. Epub 2006 Oct 24.'}, {'pmid': '17058078', 'type': 'BACKGROUND', 'citation': 'Nestle U, Schaefer-Schuler A, Kremp S, Groeschel A, Hellwig D, Rube C, Kirsch CM. Target volume definition for 18F-FDG PET-positive lymph nodes in radiotherapy of patients with non-small cell lung cancer. Eur J Nucl Med Mol Imaging. 2007 Apr;34(4):453-62. doi: 10.1007/s00259-006-0252-x. Epub 2006 Oct 21.'}, {'pmid': '16085592', 'type': 'BACKGROUND', 'citation': 'Nestle U, Kremp S, Schaefer-Schuler A, Sebastian-Welsch C, Hellwig D, Rube C, Kirsch CM. Comparison of different methods for delineation of 18F-FDG PET-positive tissue for target volume definition in radiotherapy of patients with non-Small cell lung cancer. J Nucl Med. 2005 Aug;46(8):1342-8.'}, {'pmid': '19100641', 'type': 'BACKGROUND', 'citation': 'MacManus M, Nestle U, Rosenzweig KE, Carrio I, Messa C, Belohlavek O, Danna M, Inoue T, Deniaud-Alexandre E, Schipani S, Watanabe N, Dondi M, Jeremic B. Use of PET and PET/CT for radiation therapy planning: IAEA expert report 2006-2007. Radiother Oncol. 2009 Apr;91(1):85-94. doi: 10.1016/j.radonc.2008.11.008. Epub 2008 Dec 25.'}, {'pmid': '19060363', 'type': 'BACKGROUND', 'citation': 'Nestle U, Weber W, Hentschel M, Grosu AL. Biological imaging in radiation therapy: role of positron emission tomography. Phys Med Biol. 2009 Jan 7;54(1):R1-25. doi: 10.1088/0031-9155/54/1/R01. Epub 2008 Dec 5.'}, {'pmid': '18661128', 'type': 'BACKGROUND', 'citation': 'Schaefer A, Kremp S, Hellwig D, Rube C, Kirsch CM, Nestle U. A contrast-oriented algorithm for FDG-PET-based delineation of tumour volumes for the radiotherapy of lung cancer: derivation from phantom measurements and validation in patient data. Eur J Nucl Med Mol Imaging. 2008 Nov;35(11):1989-99. doi: 10.1007/s00259-008-0875-1. Epub 2008 Jul 26.'}, {'pmid': '36130693', 'type': 'DERIVED', 'citation': 'Craddock M, Nestle U, Koenig J, Schimek-Jasch T, Kremp S, Lenz S, Banfill K, Davey A, Price G, Salem A, Faivre-Finn C, van Herk M, McWilliam A. Cardiac Function Modifies the Impact of Heart Base Dose on Survival: A Voxel-Wise Analysis of Patients With Lung Cancer From the PET-Plan Trial. J Thorac Oncol. 2023 Jan;18(1):57-66. doi: 10.1016/j.jtho.2022.09.004. Epub 2022 Sep 18.'}, {'pmid': '32171429', 'type': 'DERIVED', 'citation': 'Nestle U, Schimek-Jasch T, Kremp S, Schaefer-Schuler A, Mix M, Kusters A, Tosch M, Hehr T, Eschmann SM, Bultel YP, Hass P, Fleckenstein J, Thieme A, Stockinger M, Dieckmann K, Miederer M, Holl G, Rischke HC, Gkika E, Adebahr S, Konig J, Grosu AL; PET-Plan study group. Imaging-based target volume reduction in chemoradiotherapy for locally advanced non-small-cell lung cancer (PET-Plan): a multicentre, open-label, randomised, controlled trial. Lancet Oncol. 2020 Apr;21(4):581-592. doi: 10.1016/S1470-2045(20)30013-9. Epub 2020 Mar 12.'}, {'pmid': '26277100', 'type': 'DERIVED', 'citation': 'Nestle U, Rischke HC, Eschmann SM, Holl G, Tosch M, Miederer M, Plotkin M, Essler M, Puskas C, Schimek-Jasch T, Duncker-Rohr V, Ruhl F, Leifert A, Mix M, Grosu AL, Konig J, Vach W. Improved inter-observer agreement of an expert review panel in an oncology treatment trial--Insights from a structured interventional process. Eur J Cancer. 2015 Nov;51(17):2525-33. doi: 10.1016/j.ejca.2015.07.036. Epub 2015 Aug 12.'}]}, 'descriptionModule': {'briefSummary': 'Simultaneous radio-chemotherapy in advanced non-small cell lung cancer. The study focusses on a randomised comparison of conventional radiotherapy planning with irradiation of macroscopic tumor and lymph nodes together with prophylactic target volumes vs. irradiation only of FDG-positive lesions.\n\nPrimary endpoint is the local disease control in the chest.', 'detailedDescription': 'Simultaneous radio-chemotherapy in advanced non-small cell lung cancer. The study focusses on a randomised comparison of conventional radiotherapy planning with irradiation of macroscopic tumor and lymph nodes together with prophylactic target volumes vs. irradiation only of FDG-positive lesions.\n\nPrimary endpoint is the local disease control in the chest'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically proved NSCLC\n* UICC-stage I-III, no resection planned\n* complete staging \\< 6 wks before treatment including cranial CT\n* ECOG \\<3, Karnofsky-Index \\>60%\n* age \\> 18 \\<\n* FEV1 \\> 1,0 l or \\>35%\n* RT-planning according to protocol feasible\n* chemotherapy feasible\n* written informed consent\n\nExclusion Criteria:\n\n* neuroendocrine tumors, plain broncho-alveolar-cell ca.\n* distant metastases, supraclavicular lymph node metastases\n* malignant pleural effusion\n* resection of actual tumor performed\n* inclusion in other study protocol\n* chemotherapy due to actual tumor before FDG-PET\n* induction-chemotherapy\n* acute vena cava superior syndrome\n* second malignancy other than basalioma\n* pregnancy, lactation\n* heart insufficiency NYHA III/IV\n* pneumoconiosis with active inflammatory changes of mediastinal lymph nodes\n* acute broncho-pulmonary infection at time of PET-examination'}, 'identificationModule': {'nctId': 'NCT00697333', 'acronym': 'PET-Plan', 'briefTitle': 'Radiotherapy Planning Based on Positron Emission Tomography With Fluoro-deoxyglucose For Advanced NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN'}, 'officialTitle': 'Optimisation of Radiotherapy-Planning in Patients With Inoperable Locally Advanced Non-Small-Cell Lung Cancer by FDG-PET', 'orgStudyIdInfo': {'id': 'AG NUK/RT 2006-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'A', 'description': 'Irradiation of all tumor manifestations detectable by CT and/or positron emission tomography using fluoro-deoxy-glucose including a part of eventual atelectasis and the whole affected lymph node stations by 60 - 74 Gy/2Gy) irradiation of elective lymph node stations up to 50 Gy/2 Gy'}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Irradiation of all tumor manifestations detectable by positron emission tomography using fluoro-deoxy-glucose including the whole affected lymph node stations by 60 - 74 Gy/2Gy', 'interventionNames': ['Procedure: restriction of radiotherapy to FDG-PET positive areas only']}], 'interventions': [{'name': 'restriction of radiotherapy to FDG-PET positive areas only', 'type': 'PROCEDURE', 'description': 'Restriction of target volumes to areas positive in positron emission tomography using fluoro-deoxy-glucose', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-79106', 'city': 'Freiburg I. Br.', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ursula Nestle, Prof.', 'role': 'CONTACT', 'email': 'ursula.nestle@uniklinik-freiburg.de', 'phone': '49-761-270', 'phoneExt': '95390'}, {'name': 'A.-L. Grosu, Prof.', 'role': 'CONTACT', 'email': 'anca.grosu@uniklinik-freiburg.de', 'phone': '49-761-270', 'phoneExt': '94610'}], 'facility': 'Universitätsklinikum Freiburg'}, {'zip': 'D-79106', 'city': 'Freiburg i.Br.', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'T. Schimek-Jasch, MD', 'role': 'CONTACT', 'email': 'tanja.schimek-jasch@uniklinik-freiburg.de', 'phone': '49-761-270', 'phoneExt': '95201'}, {'name': 'S. Adebahr, MD', 'role': 'CONTACT', 'email': 'sonja.adebahr@uniklinik-freiburg.de', 'phone': '49-761-270', 'phoneExt': '95371'}, {'name': 'Ursula Nestle, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Freiburg'}], 'centralContacts': [{'name': 'U. Nestle, Prof.', 'role': 'CONTACT', 'email': 'ursula.nestle@uniklinik-freiburg.de', 'phone': '49-761-270', 'phoneExt': '95390'}, {'name': 'A. L. Grosu, Prof.', 'role': 'CONTACT', 'email': 'anca.grosu@uniklinik-freiburg.de', 'phone': '49-761-270', 'phoneExt': '94610'}], 'overallOfficials': [{'name': 'Ursula Nestle, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Freiburg, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Ursula Nestle, Universitätsklinikum Freiburg', 'investigatorFullName': 'Prof. Dr. Ursula Nestle', 'investigatorAffiliation': 'Arbeitsgemeinschaft Nuklearmedizin und Strahlentherapie der DEGRO und DGN'}}}}