Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-02-28 @ 5:30 AM
Study NCT ID:
NCT02407912
Status:
UNKNOWN
Last Update Posted:
2015-11-20
First Post:
2015-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cisplatin for Malignant Pleural Effusion in Patients With Non-small-cell 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-18', 'studyFirstSubmitDate': '2015-03-31', 'studyFirstSubmitQcDate': '2015-04-02', 'lastUpdatePostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall response rate', 'timeFrame': 'one month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pleural Effusion, Malignant']}, 'descriptionModule': {'briefSummary': 'To assess the effect and toxicity of intrapleural administration of hypertonic cisplatin for malignant pleural effusion in patients with non-small-cell lung cancer.', 'detailedDescription': 'The lung was fully expanded by a thoracostomy using a chest tube with a double lumen, and then the patients were enrolled into the trial.First, premedication including antiemetics and hydration were performed. Thereafter, 75 mg of body surface area of cisplatin in 50 ml of distilled water was injected through a chest tube.The patients were asked to change position (supine and bilateral decubital) from time to time for 30 minutes. The chest tube was clamped for 48 h and then the tube was declamped and allowed to drain. When the drainage effusion was less than 100 ml a day, the chest tube was removed. Any patient whose drainage effusion continued for over 2 weeks was withdrawn from the trial and was also judged to be a nonresponder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cytologically proven and previously untreated malignant pleural effusion of Non-small-cell Lung Cancer;\n* An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1;\n* A leucocyte count of≥4000µl;\n* A platelet count of≥100000µl;\n* A normal creatinine level;\n* Serum glutamic oxaloacetic transaminase/glutamic pyruvic transaminase levels of no more than twice the upper limit of normal;\n* Survival time ≥12 weeks.\n\nExclusion Criteria:\n\n* Previously treated malignant pleural effusion;\n* Pericardial effusion；\n* Pregnant；\n* Uncontrolled hypertension or diabetes；\n* Liver cihrosis.'}, 'identificationModule': {'nctId': 'NCT02407912', 'briefTitle': 'Cisplatin for Malignant Pleural Effusion in Patients With Non-small-cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shantou University Medical College'}, 'officialTitle': 'Intrapleural Hypertonic Cisplatin Treatment for Malignant Pleural Effusion in Patients With Non-small-cell Lung Cancer.', 'orgStudyIdInfo': {'id': 'LXY 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cisplatin', 'description': '75 mg of body surface area of ciplatin in distilled water is injected in to the chest through a chesttube.', 'interventionNames': ['Drug: cisplatin']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention was applied.'}], 'interventions': [{'name': 'cisplatin', 'type': 'DRUG', 'otherNames': ['cisplatinum'], 'description': 'ciplatin in distilled water is injected into the chest for 48 h.', 'armGroupLabels': ['Cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '515031', 'city': 'Shantou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongbiao Wang, Master', 'role': 'CONTACT', 'email': 'wanghongbiao123@qq.com', 'phone': '8613592882093'}], 'facility': 'Department of medical oncology', 'geoPoint': {'lat': 23.35489, 'lon': 116.67876}}], 'centralContacts': [{'name': 'Hongbiao Wang, Master', 'role': 'CONTACT', 'email': 'wanghongbiao123@qq.com', 'phone': '8613592882093'}], 'overallOfficials': [{'name': 'Hongbiao Wang, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Cancer Hospital of Shantou University Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shantou University Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate chief physician', 'investigatorFullName': 'Hongbiao Wang', 'investigatorAffiliation': 'Shantou University Medical College'}}}}