Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-27 @ 2:53 AM
Study NCT ID:
NCT02364804
Status:
COMPLETED
Last Update Posted:
2020-09-01
First Post:
2015-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy of Anti-emetic Drug Upon the Combination Chemotherapy for 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077608', 'term': 'Aprepitant'}], 'ancestors': [{'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-28', 'studyFirstSubmitDate': '2015-02-02', 'studyFirstSubmitQcDate': '2015-02-10', 'lastUpdatePostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of anti-emetic drug efficacy: Incidence and grade of nausea/vomiting', 'timeFrame': 'Fifteen days after beginning of each cycle of chemotherapy'}], 'secondaryOutcomes': [{'measure': 'Influence on clinical outcome: Survival', 'timeFrame': 'Participants will be followed for 3 years after the last treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of anti-emetic drug Aprepitant upon the combination chemotherapy of nedaplatin and docetaxel for non-small cell lung cancer (NSCLC).', 'detailedDescription': 'The purpose of this study is to evaluate the efficacy of anti-emetic drug Aprepitant upon the combination chemotherapy of nedaplatin and docetaxel for non-small cell lung cancer (NSCLC). The incidence and grade of chemotherapy-induced nausea and vomit (CINV) will be assessed in patients receiving Aprepitant for the prevention of CINV upon the combination chemotherapy of nedaplatin and docetaxel for NSCLC. These data will be compared with those surveyed retrospectively in patients who had received the combination chemotherapy with anti-emetic agents except Aprepitant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Non-small cell lung cancer patients who receive the combination chemotherapy of nedaplatin and docetaxel', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who receive the combination chemotherapy of nedaplatin and docetaxel as a treatment or an adjuvant therapy for non-small cell lung cancer.\n2. ECOG performance status 0-1.\n3. Aged 20-79 years old.\n4. Laboratory values as follows 4000/mm3 \\< WBC \\< 12000/mm3, neutrophil count \\> 2000/mm3, platelet count \\> 100000/mm3, hemoglobin \\> 9.5g/dL, asparate transaminase \\< 2.5 X cutoff value, alanine transaminase \\< 2.5 X cutoff value, total bilirubin \\< 1.5g/dL, Serum creatinine \\< cutoff value, PaO2 \\> 60 Torr.\n5. Able and willing to give valid written informed consent.\n\nExclusion Criteria:\n\n1. Allergy against polysorbert 80 or platinum-containing drugs.\n2. Severe complications (i.e. ischemic heart diseases required treatment, arrhythmia, myocardial infarction within 6 months, liver cirrhosis, uncontrolled diabetes, and hemorrhagic tendency).\n3. Active and uncontrolled infectious disease.\n4. Massive pleural or pericardial effusion.\n5. Other malignancy requiring treatment.\n6. Active interstitial pneumonitis or its past historyBreastfeeding and Pregnancy (woman of child bearing potential)\n7. Peripheral nerve disorder.\n8. Pregnant or lactating women.\n9. Concurrent administration of pimozide.\n10. Decision of unsuitableness by principal investigator or physician-in-charge'}, 'identificationModule': {'nctId': 'NCT02364804', 'briefTitle': 'A Study to Evaluate the Efficacy of Anti-emetic Drug Upon the Combination Chemotherapy for Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shiga University'}, 'officialTitle': 'A Study to Evaluate the Efficacy of Anti-emetic Drug Aprepitant Upon the Combination Chemotherapy of Nedaplatin and Docetaxel for Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '24-20'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Aprepitant', 'type': 'DRUG', 'otherNames': ['Emend'], 'description': 'The incidence and grade of chemotherapy-induced nausea and vomit (CINV) will be assessed in patients receiving Aprepitant for the prevention of CINV upon the combination chemotherapy of nedaplatin and docetaxel for NSCLC. These data will be compared with those surveyed retrospectively in patients who had received the combination chemotherapy with anti-emetic agents but Aprepitant.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '520-2192', 'city': 'Ōtsu', 'state': 'Shiga', 'country': 'Japan', 'facility': 'Shiga University of Medical Science Hospital', 'geoPoint': {'lat': 35.0, 'lon': 135.86667}}], 'overallOfficials': [{'name': 'Yataro Daigo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shiga University of Medical Science'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shiga University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yataro Daigo', 'investigatorAffiliation': 'Shiga University'}}}}