Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-12 @ 10:04 PM
Study NCT ID:
NCT03394105
Status:
COMPLETED
Last Update Posted:
2019-03-08
First Post:
2017-10-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrapleural Docetaxel Administration Using Medical Pleuroscopy in Malignant Effusion With Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016066', 'term': 'Pleural Effusion, Malignant'}], 'ancestors': [{'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010996', 'term': 'Pleural Effusion'}, {'id': 'D010995', 'term': 'Pleural 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': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-06', 'studyFirstSubmitDate': '2017-10-09', 'studyFirstSubmitQcDate': '2018-01-03', 'lastUpdatePostDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall respose rate(ORR)', 'timeFrame': 'through study completion (2.5 years)', 'description': 'Rate of CR and PR'}, {'measure': 'Complete resonse (CR) rate', 'timeFrame': 'through study completion (2.5 years)'}], 'secondaryOutcomes': [{'measure': 'Time to progression(TTP)', 'timeFrame': 'through study completion (2.5 years)', 'description': 'time from the date of the start of treatment until the disease progression or death.'}, {'measure': 'Overall survival(OS)', 'timeFrame': 'through study completion (2.5 years)', 'description': 'time fromthe date of the start of treatment to death or the date of last follow-up'}, {'measure': 'Adverse Event', 'timeFrame': 'through study completion (2.5 years)', 'description': 'Based on National Cancer Institute Common Toxicity Criteria'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pleurodesis'], 'conditions': ['Pleural Effusion, Malignant', 'Non-small Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'In this trial, the effect of intrapleural docetaxel administration using medical pleuroscopywill be evaluated in Lung Cancer patient with malignant effusion.', 'detailedDescription': 'This study is designed to be pilot, single-center, open-label, single-arm, prospective, phase II trial of patient with NSCLC with pleurla effusion. Approximately 40 patients will be enrolled into the trial, and study will be performed to 31Dec2018 from IRB and Korea: MFDS approval date.\n\nDocetaxel will be administed to interpleural space using medical pleuroscopy in malignant effusion with lung cancer. Response evaluation will be done until confiramtion of disease progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 20, and NSCLC patients with malignant pleural effusion and related symptoms\n* ECOG ≤ 2\n* Blood test ANC≥ 1500/mm3, Hb ≥ 8.0g/dl, platelet count ≥ 100000/mm3 Serum creatinine ≤ 1.8mg/dl, Total bilirubin within normal limits, Transaminases ≤ 1.5 x UNL, Alkaline phosphatase ≤ 2.5 X UNL BUN ≤ 25mg/dl, Creatinine clearance ≥ 50ml/min\n* Negative serum or urine pregnancy test for women for childbearing age\n* Patients who provide written informed consent for the study\n\nExclusion Criteria:\n\n* Age \\< 20\n* Patients who were previously perfomed pleurodesis\n* Patients who were previously treated with thoracic radiosurgery\n* Patinet with bilateral pleural effusion\n* Age ≥ 80yrs\n* Patients with histories of hypersensitivity to Docetaxel\n* Patients with cardiovascular, respiratory, hepatic, renal, gastrointestinal, neunological disease, asthma, MI, stroke, arrhythmia, uncontrolled hypertionsion, etc. that would effect absorption, distribution, and metabolism of IP or be risk factors during IP administrion.\n* Patients who could not understand the study procedure'}, 'identificationModule': {'nctId': 'NCT03394105', 'briefTitle': 'Intrapleural Docetaxel Administration Using Medical Pleuroscopy in Malignant Effusion With Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Pilot Study to Evaluate the Effect of Intrapleural Docetaxel Administration Using Medical Pleuroscopy in Malignant Effusion With Lung Cancer', 'orgStudyIdInfo': {'id': 'C2015-00353_Pleurodesis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intrapleural docetaxel administration', 'description': 'Docetaxel will be administed to interpleural space using medical pleuroscopy in malignant effusion with lung cancer.', 'interventionNames': ['Drug: intrapleural docetaxel administration']}], 'interventions': [{'name': 'intrapleural docetaxel administration', 'type': 'DRUG', 'otherNames': ['Pleurodesis_docetaxel'], 'description': 'intrapleural docetaxel administration using medical pleuroscopy in malignant effusion with lung cancer', 'armGroupLabels': ['intrapleural docetaxel administration']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'CHANG-MIN CHOI, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Chang-Min Choi', 'investigatorAffiliation': 'Asan Medical Center'}}}}