Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT00938418
Status:
UNKNOWN
Last Update Posted:
2009-07-13
First Post:
2009-07-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hypofractionated Intensity Modulated Chemoradiotherapy to Treat Locally 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'}], '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 43}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'lastUpdateSubmitDate': '2009-07-10', 'studyFirstSubmitDate': '2009-07-10', 'studyFirstSubmitQcDate': '2009-07-10', 'lastUpdatePostDateStruct': {'date': '2009-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Response rate, locoregional control, disease free survival, toxicity', 'timeFrame': '2 years'}]}, 'conditionsModule': {'conditions': ['Stage III Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Locally advanced non-small cell lung cancer can be treated successfully with chemotherapy and radiation. However, the cure rate is low.\n\nThis study is carried out to find out whether giving radiotherapy at a higher dose over fewer treatment sessions with intensity modulated radiotherapy (IMRT) can improve the treatment outcome.\n\nThis study aims to recruit 43 patients from National University Hospital and Tan Tock Seng Hospital over a period of about 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically proven (either histologic or cytologic) diagnosis of Stage IIIA or IIIB non-small cell lung cancer; excluding patients with N3 disease based on supraclavicular or contralateral hilar adenopathy, or significant pleural / pericardial effusion.\n\nExclusion Criteria:\n\n* Patients for whom treatment is planned with a maximum dose of ≥ 66 Gy to the ipsilateral brachial plexus\n* Greater than minimal, exudative, or cytologically positive pleural effusions\n* ≥ 10% weight loss within the past month\n* Prior invasive malignancy (with exceptions)\n* Prior radiotherapy to the region of the study cancer\n* Significant co-morbidities\n* Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception\n* Known allergic reactions to components of planned chemotherapy regimen'}, 'identificationModule': {'nctId': 'NCT00938418', 'briefTitle': 'Hypofractionated Intensity Modulated Chemoradiotherapy to Treat Locally Advanced Non-Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'National University Hospital, Singapore'}, 'officialTitle': 'Phase II Study on Dose Escalated, Accelerated Hypofractionated Intensity Modulated Radiotherapy for Stage III Non-Small Cell Lung Cancer With Concurrent Chemotherapy', 'orgStudyIdInfo': {'id': 'B/09/108'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dose escalated, accelerated, hypofractionated radiotherapy', 'type': 'RADIATION', 'description': 'Intensity modulated radiotherapy with concurrent chemotherapy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Jay Lu, MD', 'role': 'CONTACT', 'phone': '6567724870'}], 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Cheng Nang Leong, MD', 'role': 'CONTACT', 'phone': '6563571070'}, {'name': 'Cheng Nang Leong, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tan Tock Seng Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Ivan Tham, MD', 'role': 'CONTACT', 'email': 'ivan_wk_tham@nuh.com.sg', 'phone': '6567724870'}, {'name': 'Jay Lu, MD', 'role': 'CONTACT', 'phone': '6567724870'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University Hospital, Singapore', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tan Tock Seng Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr Ivan Tham', 'oldOrganization': 'National University Health System'}}}}