Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-01 @ 2:53 PM
Study NCT ID:
NCT00907569
Status:
COMPLETED
Last Update Posted:
2016-02-22
First Post:
2009-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypofractionated Radiotherapy for Limited Stage Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D018288', 'term': 'Carcinoma, Small Cell'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], 'ancestors': [{'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': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-18', 'studyFirstSubmitDate': '2009-05-20', 'studyFirstSubmitQcDate': '2009-05-21', 'lastUpdatePostDateStruct': {'date': '2016-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2-year overall survival', 'timeFrame': '2011'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '2011'}, {'measure': 'Patterns of Failure', 'timeFrame': '2011'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Small cell lung cancer', 'radiotherapy dose escalation'], 'conditions': ['Lung Neoplasm', 'Small Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'It is accepted that giving higher doses of chest radiation in as short a time span as possible improves chances of cure. In this study, the investigators propose to give an increased dose of chest radiotherapy for limited stage small cell lung cancer patients using a strategy of giving a slightly higher daily dose of radiotherapy than normal. The investigators hypothesize that our proposed chest radiotherapy dose will improve 2-year overall survival rates in patients with limited stage small cell lung cancer.', 'detailedDescription': 'The ideal chest radiotherapy dose/fractionation scheme for limited stage small cell lung cancer is undefined. Strategies of radiotherapy dose intensification with minimization of overall treatment time are felt to improve cure rates for LS-SCLC. Hypofractionation (giving higher than standard daily doses) facilitates both of these goals. In this study, we propose to use a dose escalated hypofractionated regimen of chest radiotherapy for patients with LS-SCLC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* limited stage small cell lung cancer\n* adequate pulmonary function test (FEV1 \\>1.0 L, DLCO \\>50%)\n* signed study consent\n* age at least 18 years\n* Karnofsky performance status as least 70%\n* eligible to receive standard concurrent small cell cancer chemotherapy\n\nExclusion Criteria:\n\n* extensive stage disease\n* mixed non small cell and small cell histology\n* inadequate pulmonary function tests\n* not eligible for concurrent chemotherapy\n* subtotal or total tumor resection\n* previous chest/neck radiotherapy\n* prior or concurrent malignancy except non-melanomatous skin unless disease free for last 5 years\n* pregnant\n* prior chemotherapy for another malignancy\n* patients with myocardial infarction within the preceding 6 months of symptomatic heart disease, including, angina, congestive heart failure, uncontrolled arrhythmias'}, 'identificationModule': {'nctId': 'NCT00907569', 'briefTitle': 'Hypofractionated Radiotherapy for Limited Stage Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'AHS Cancer Control Alberta'}, 'officialTitle': 'A Clinical Trial of Increased Chest Radiotherapy Dose for Limited Stage Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '24762'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Hypofractionated Chest Radiotherapy', 'type': 'RADIATION', 'description': 'Hypofractionated chest radiotherapy regimen of 58 Gy delivered in 25 fractions in 5 weeks.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Cross Cancer Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AHS Cancer Control Alberta', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cross Cancer Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}