Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-29 @ 12:02 PM
Study NCT ID:
NCT01941303
Status:
COMPLETED
Last Update Posted:
2016-03-22
First Post:
2013-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Treatment Outcome and Toxicity in Non-small Cell Lung Cancer Patients Wither-irradiated to a High Dose for Recurrent Disease
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-21', 'studyFirstSubmitDate': '2013-09-03', 'studyFirstSubmitQcDate': '2013-09-09', 'lastUpdatePostDateStruct': {'date': '2016-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '1 year after radiotherapy', 'description': 'Measuring survival by checking if patients are alive.'}, {'measure': 'Locoregional control', 'timeFrame': '1 year after radiotherapy', 'description': 'Measuring locoregional control by checking pt for progression'}, {'measure': 'Progression-free survival', 'timeFrame': '1 year after radiotherapy', 'description': 'Checking patients for progression'}], 'secondaryOutcomes': [{'measure': 'Pulmonary toxicity', 'timeFrame': '1 year after radiotherapy', 'description': 'Checking patients for pulmonary adverse events'}, {'measure': 'Oesophageal toxicity', 'timeFrame': '1 year after radiotherapy', 'description': 'Checking patients for oesophageal adverse events'}, {'measure': 'Other dose-limiting or burdensome toxicity', 'timeFrame': '1 year after radiotherapy', 'description': 'Checking patients fortoxicity which causes problems with regard to radiotherapy-dose or is otherwise burdensome'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Non-small cell lung cancer'], 'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'As one of the few centers, MAASTRO also aggressively re-treats patients with recurrent non-small cell lung cancer. Even after primary radical treatment to high doses, re-irradiation (with concurrent chemotherapy) is also given in curative intent, thus again using high doses of radiation.\n\nPublications on high-dose re-irradiation of lung cancer patients are scarce, and outcome and toxicity for patients treated in MAASTRO are unknown at present. This study will provide knowledge on benefit and risks of such a therapeutic approach.', 'detailedDescription': 'MAASTRO clinic is a leader in the (individual) management of patients with lung cancer. This has resulted in major publications in the past on individualized (chemo)radiotherapy for (NSCLC) \\[van Baardwijk 2006 and 2010\\]. As one of the few centers, MAASTRO also aggressively re-treats patients with recurrent non-small cell lung cancer. Even after primary radical treatment to high doses, re-irradiation is also given in curative intent, thus again using high doses of radiation.\n\nPublications on this topic are rare. Most reports address the results of palliative re-irradiation of NSCLC \\[Ebara 2007, Jackson 1987, Montebello 1993, Tada 2005\\]. The ones available on re-irradiation with curative intent used outdated techniques \\[Okamoto 2002, Wu 2003\\]. Only one recent publication has analyzed the results of 37 NSCLC patients of whom 9 were re-irradiated with at least 50 Gy using helical tomotherapy \\[Kruser in press\\].\n\nThe results of radical re-irradiation applying highly conformal radiation techniques within MAASTRO are unknown. This study will provide knowledge on benefit and risks of such a therapeutic approach. Furthermore, it may provide enough evidence to initiate a Phase II/III clinical trial for re-irradiation of NSCLC patients with curative intent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with non-small cell lung cancer undergoing chest irradiation (with chemotherapy) to a radical dose twice: in the primary and the recurrent setting.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patients with advanced stage non-small cell lung cancer treated to higher doses of irradiation (i.e. EQD2\\>50Gy) twice: in the primary and recurrent setting.'}, 'identificationModule': {'nctId': 'NCT01941303', 'briefTitle': 'Analysis of Treatment Outcome and Toxicity in Non-small Cell Lung Cancer Patients Wither-irradiated to a High Dose for Recurrent Disease', 'nctIdAliases': ['NCT01930825'], 'organization': {'class': 'OTHER', 'fullName': 'Maastricht Radiation Oncology'}, 'officialTitle': 'Radical Re-irradiation of Recurrent NSCLC - Analysis of Outcome and Toxicity.', 'orgStudyIdInfo': {'id': 'Irradiation treatment outcome'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Advanced stage non-small cell lung cancer patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229 ET', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'MAASTRO clinic', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Esther Troost, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastro Clinic, The Netherlands'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht Radiation Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}