Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT00349102
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2006-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention of Radiation Pneumonitis After Three-dimensional Conformal Radiation Therapy (3D-CRT) in Patients With 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': 'D017564', 'term': 'Radiation Pneumonitis'}], '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'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062485', 'term': 'Breath Holding'}], 'ancestors': [{'id': 'D012119', 'term': 'Respiration'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-31', 'studyFirstSubmitDate': '2006-07-05', 'studyFirstSubmitQcDate': '2006-07-05', 'lastUpdatePostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical, functional and radiological evaluations at 6-8 weeks and 10-12 weeks after the end of irradiation', 'timeFrame': '6-8 and 10-12 weeks after the end of irradiation'}], 'secondaryOutcomes': [{'measure': 'RTOG and LENT-SOMA scores at 6-8 weeks and 10-12 weeks after the end of irradiation, response rates at 6-8 weeks, 1 year and 2 years after irradiation', 'timeFrame': '6-8 and 10-12 weeks after the end of irradiation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Non-small-cell lung cancer', 'Breath-hold', 'Radiation pneumonitis', 'Serum cytokines', 'LENT-SOMA scale', 'Non-metastatic non-small-cell lung cancer'], 'conditions': ['Carcinoma, Non-small-cell Lung']}, 'referencesModule': {'references': [{'pmid': '16314635', 'type': 'BACKGROUND', 'citation': 'Arpin D, Perol D, Blay JY, Falchero L, Claude L, Vuillermoz-Blas S, Martel-Lafay I, Ginestet C, Alberti L, Nosov D, Etienne-Mastroianni B, Cottin V, Perol M, Guerin JC, Cordier JF, Carrie C. Early variations of circulating interleukin-6 and interleukin-10 levels during thoracic radiotherapy are predictive for radiation pneumonitis. J Clin Oncol. 2005 Dec 1;23(34):8748-56. doi: 10.1200/JCO.2005.01.7145.'}, {'pmid': '15110451', 'type': 'BACKGROUND', 'citation': 'Claude L, Perol D, Ginestet C, Falchero L, Arpin D, Vincent M, Martel I, Hominal S, Cordier JF, Carrie C. A prospective study on radiation pneumonitis following conformal radiation therapy in non-small-cell lung cancer: clinical and dosimetric factors analysis. Radiother Oncol. 2004 May;71(2):175-81. doi: 10.1016/j.radonc.2004.02.005.'}, {'type': 'RESULT', 'citation': 'L. Falchero, D. Perol, D. Arpin, M. Vincent, M. Perol, JF. Cordier, D. Boutry, I. Martel-Lafay, C. Carrie.- Conséquences fonctionnelles de la radiothérapie thoracique conformationnelle (r3d) et facteurs prédictifs de pneumopathie radique aiguë (PRA) chez des patients atteints de cancer bronchique non à petites cellules (CNPC). Rev. Mal. Resp., 2001 ; 18 (suppl) : 1S102'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the interest of breath holding for the prevention of radiation pneumonitis following conformal radiation therapy.\n\nEligible patients will be randomly assigned in a 2-arm trial to free breathing or breath holding during conformal radiation.\n\nThe primary objective of the study is to establish the efficacy of breath holding, compared to free breathing, in the prevention of early pulmonary toxicity following conformal radiation.\n\nSeveral departments of radiotherapy, many pneumology units and two basic and applied research laboratories take part in this multicentric study.\n\nThe number of patients required to demonstrate a reduction in radiation pneumonitis from 45 % to 22.5 %, assuming an alpha risk of 5% in a two-sided test and 95% power, is 240 (120 per arm). With a planned accrual of 7 patients per month, it is estimated that the inclusion period should be approximately 3 years.', 'detailedDescription': 'The secondary objectives are:\n\n* Validation of the Lent-Soma toxicity scale by comparison to the RTOG scale,\n* Response rate at different times: week 6-8, 1 year and 2 years after the end of irradiation,\n* Progression-free survival rate at 1 year and 2 years after the end of irradiation\n* Confirmation of the predictive value of serum cytokine levels (IL-6 and IL-10) during irradiation for the occurrence of early radiation toxicity, and analysis of the correlation between these serum levels at inclusion and the expression polymorphism of candidate genes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-metastatic cytologically or histologically proven non-small-cell lung cancer (NSCLC)\n* Operated NSCLC patients requiring post-surgical irradiation or non-operated NSCLC patients requiring curative irradiation\n* Conformational thoracic radiotherapy with curative intent\n* Age \\>= 18\n* Complete functional respiratory evaluation (FRE) performed less than 2 months before inclusion, demonstrating a maximum expiratory flow-volume/second \\> 1 l (in case surgery, the FRE must have been realized in the post-surgery period)\n* Thoracic CT-scan performed less than 2 months before inclusion for non-operated patient\n* PET-scan performed less than 2 months before inclusion for non-operated patient\n* Performance status (PS) ECOG \\<= 1\n* Possible training on breath holding technique\n* Female patients of childbearing potential: effective method of contraception necessary\n* Mandatory affiliation with a social security system\n* Written, signed, informed consent\n\nExclusion Criteria:\n\n* Small-cell lung cancer\n* Metastatic disease\n* Infiltrating pulmonary disease\n* Previous thoracic irradiation\n* Indication of irradiation with palliative intent\n* Previous or concurrent primary malignancies at other sites (except basocellular skin cancer or cervical cancer in situ or complete remission for more than 5 years)\n* Life expectancy \\< 6 months\n* Patient understanding incompatible with the breath-hold technique (patients with major presbycusis are not eligible)\n* Pregnant or lactating woman\n* Patient included in another clinical trial\n* Follow-up difficult\n* Patient deprived of freedom'}, 'identificationModule': {'nctId': 'NCT00349102', 'briefTitle': 'Prevention of Radiation Pneumonitis After Three-dimensional Conformal Radiation Therapy (3D-CRT) in Patients With Non-small-cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Centre Leon Berard'}, 'officialTitle': 'Evaluation of the Interest of Breath Holding for the Prevention of Radiation Pneumonitis Following Conformal Radiation Therapy', 'orgStudyIdInfo': {'id': 'GATING 2006'}, 'secondaryIdInfos': [{'id': 'ET2005-052'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Free breathing during conformal radiation', 'interventionNames': ['Radiation: Free breathing']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Breath holding during conformal radiation', 'interventionNames': ['Radiation: Breath holding']}], 'interventions': [{'name': 'Free breathing', 'type': 'RADIATION', 'otherNames': ['Conformal radiation', 'Lung cancer'], 'description': 'Free breathing during conformal radiation', 'armGroupLabels': ['A']}, {'name': 'Breath holding', 'type': 'RADIATION', 'otherNames': ['Conformal radiation', 'Lung cancer'], 'description': 'Breath holding during conformal radiation', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69008', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '75005', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital de la Pitié Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '66000', 'city': 'Perpignan', 'country': 'France', 'facility': "Centre Catalan d'Oncologie", 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}, {'zip': '44805', 'city': 'Saint-Herblain', 'country': 'France', 'facility': 'Centre René Gauducheau', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}], 'overallOfficials': [{'name': 'Line CLAUDE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Leon Berard, Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Leon Berard', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}