Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-02-21 @ 8:26 AM
Study NCT ID:
NCT01810367
Status:
COMPLETED
Last Update Posted:
2016-02-23
First Post:
2013-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in NSCLC
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': '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-22', 'studyFirstSubmitDate': '2013-03-11', 'studyFirstSubmitQcDate': '2013-03-12', 'lastUpdatePostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'from the first cycle of treatment (day one) to two month after the last cycle'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PFS'], 'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Assess the PFS/ORR/OS of ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in first Treatment of NSCLC'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '1.18\\~75 years 2.Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer 3.Presence of at least one index lesion measurable by CT scan or MRI 4.Ecog0-1 5.Expected life time longer than 12 weeks 6.Normal laboratory values:\n\n* leucocyte ≥ 4×109/L\n* neutrophil ≥ 1.5×109/L\n* platelet ≥ 100×109/L\n* Hemoglobin ≥ 10g/L\n* ALT and\n* AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis) 7.Signed written informed consent\n\nExclusion Criteria:\n\n* Patients have used drugs according to protocol\n* Patients were allergic to pemetrexed or cisplatin\n* Patients received radiotherapy or other biological treatment 4 weeks before the trial\n* Uncontrolled hydrothorax or hydropericardium\n* neuropathy toxicity ≥ CTC 3\n* Severe symptomatic heart disease\n* Active upper gastrointestinal ulcer or digestive disfunction\n* Severe infection or metabolic disfunction\n* Patients with other malignant tumor\n* Uncontrolled brain metastases\n* Patients have accepted other clinical trials\n* Female patients during their pregnant and lactation period, or patients without contraception'}, 'identificationModule': {'nctId': 'NCT01810367', 'briefTitle': 'ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in First Line Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer Stage II Randomized Controlled Trials', 'orgStudyIdInfo': {'id': 'ABX-CJH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABX Combined With Cisplatin', 'description': 'ABX，100mg/m2，d1、8、15，ivgtt,in 30 min，28day one cycle； cisplin 75mg/m2 d1 ivgtt', 'interventionNames': ['Drug: ABX Combined With Cisplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gemcitabine Combined With Cisplatin', 'description': 'gemcitabine 1000mg/m2，d1、8；cisplatin 75mg/m2 d1 ivgtt,3 weeks one cycle.', 'interventionNames': ['Drug: Gemcitabine Combined With Cisplatin']}], 'interventions': [{'name': 'ABX Combined With Cisplatin', 'type': 'DRUG', 'armGroupLabels': ['ABX Combined With Cisplatin']}, {'name': 'Gemcitabine Combined With Cisplatin', 'type': 'DRUG', 'armGroupLabels': ['Gemcitabine Combined With Cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Cancer hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice director of department of chemotherapy', 'investigatorFullName': 'Chang Jian Hua', 'investigatorAffiliation': 'Fudan University'}}}}