Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-31 @ 11:14 AM
Study NCT ID:
NCT00886405
Status:
UNKNOWN
Last Update Posted:
2009-04-22
First Post:
2009-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concurrent Chemotherapy and Radiotherapy With Nitroglycerin in Patients With Locally Advanced Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-04-21', 'studyFirstSubmitDate': '2009-04-21', 'studyFirstSubmitQcDate': '2009-04-21', 'lastUpdatePostDateStruct': {'date': '2009-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to progression, over-all survival', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Levels of oxidative stress through lipid peroxidation and quantification of VEGF Toxicity from treatment with chemotherapy and concurrent chemo-radiotherapy combined with transdermal nitroglycerin', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nitroglycerin', 'Locally advanced non small-cell lung cancer', 'Vascular endothelial growth factor', 'Hypoxia Inducible Factor', 'Clinical stage IIIA and/or IIIB (without pleural effusion)'], 'conditions': ['Locally Advanced Non Small-Cell Lung Canger']}, 'descriptionModule': {'briefSummary': 'Nitroglycerin will increase the effectiveness of treatment with induction chemotherapy and concurrent chemo-radiotherapy by reducing chemo-radio resistance through an increased oxygen pressure in tumoral tissue. The combination treatment of nitroglycerin and chemotherapy will result in longer disease-free and over-all survival in patients with locally advanced NSCLC', 'detailedDescription': 'Nitroglycerin decreases hypoxia-induced resistance to antitumor drugs due to inhibition of Hypoxia Inducible Factor alfa (HIF-1α), it increases oxygen pressure in tumoral tissue by augmenting tumor blood flow, increases apoptosis, activation of p53, and induces cellular growth inhibition. Randomized studies showed that the addition of transdermal nitroglycerin to non small cell lung cancer (NSCLC) patients with metastasis treated with vinorelbine and cisplatin achieved a significantly better global response to treatment than conventional treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histopathologic diagnosis of non small-cell lung cancer\n* Clinical stage IIIA and/or IIIB without pleural effusion\n* ECOG functional status 0 or 1\n* No renal function alteration (GFR \\>50%)\n* No hepatic function alteration (ALT and AST less than 2 times its normal value)\n* Leucocytes more than 2,000/mcl\n* Hemoglobin more than 10mg/dL\n* Platelets more than 100,000/mcl\n\nExclusion Criteria:\n\n* Ischemic heart disease\n* Abnormal electrocardiogram'}, 'identificationModule': {'nctId': 'NCT00886405', 'briefTitle': 'Concurrent Chemotherapy and Radiotherapy With Nitroglycerin in Patients With Locally Advanced Non-Small Cell Lung Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Institute of Cancerología'}, 'officialTitle': 'Phase II Study That Evaluates Concurrent Chemotherapy and Radiotherapy With Nitroglycerin in Patients With Locally Advanced Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'CB332/08'}, 'secondaryIdInfos': [{'id': 'INCAN/CC/162/08'}, {'id': 'CA.030/CB332/08'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nytroglicerin', 'interventionNames': ['Drug: Transdermal nitroglycerin']}], 'interventions': [{'name': 'Transdermal nitroglycerin', 'type': 'DRUG', 'description': 'Transdermal nitroglycerin (25mg/day) during 5 days (2 days before and 3 days after chemotherapy) at the beginning of each chemotherapy cycle for a total of 4 cycles', 'armGroupLabels': ['Nytroglicerin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mexico City', 'state': 'Mexico City', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Oscar A Rodriguez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Institute of Cancerología', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Oscar A Rodriguez, MD', 'role': 'CONTACT', 'email': 'ogar@servidor.unam.mx', 'phone': '(0155)56280400', 'phoneExt': '832'}], 'overallOfficials': [{'name': 'Oscar A Rodriguez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Counsil of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Cancerología', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Oscar Arrieta Rodríguez', 'oldOrganization': 'CONACYT'}}}}