Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2025-12-30 @ 4:50 AM
Study NCT ID:
NCT01769066
Status:
COMPLETED
Last Update Posted:
2016-02-23
First Post:
2013-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum for Advanced NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D010984', 'term': 'Platinum'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'lastUpdateSubmitDate': '2016-02-22', 'studyFirstSubmitDate': '2013-01-10', 'studyFirstSubmitQcDate': '2013-01-14', 'lastUpdatePostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '12 weeks of non-progression rate', 'timeFrame': 'from the first cycle of treatment (day one) to two month after the last cycle'}], 'secondaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'from the first cycle of treatment (day one) to two month after the last cycle'}]}, 'conditionsModule': {'conditions': ['NSCLC']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to explore the Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum compare with Pemetrexed/Platinum for Advanced NSCLC.', 'detailedDescription': 'Patients will be randomized to 2 groups'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18\\~70 years\n2. Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer\n3. Presence of at least one index lesion measurable by CT scan or MRI\n4. Ecog0-1\n5. Expected life time longer than 12 weeks\n6. 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)\n7. 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': 'NCT01769066', 'briefTitle': 'Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum for Advanced NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Random Open Exploratory Clinical Research of Sequential Gefitinib With Pemetrexed/Platinum Compare With Pemetrexed/Platinum Treatment for Advanced Non-small Cell Lung Cancer Exploratory Clinical Research', 'orgStudyIdInfo': {'id': 'Gefitinib-2009-cjh'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequential Gefitinib With Pemetrexed/Platinum', 'description': 'Pemetrexed IV 500 mg/m2 ，DAY2 DDP IV 75mg/m2 ，DAY1 OR CAP IV AUC 5,DAY1 Gefitinib PO. 250mg DAY3-16', 'interventionNames': ['Drug: Sequential Gefitinib With Pemetrexed/Platinum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pemetrexed/Platinum', 'description': 'Pemetrexed IV 500 mg/m2 ，DAY2 DDP IV 75mg/m2 ，DAY1 OR CAP IV AUC 5,DAY1', 'interventionNames': ['Drug: Pemetrexed/Platinum']}], 'interventions': [{'name': 'Sequential Gefitinib With Pemetrexed/Platinum', 'type': 'DRUG', 'armGroupLabels': ['Sequential Gefitinib With Pemetrexed/Platinum']}, {'name': 'Pemetrexed/Platinum', 'type': 'DRUG', 'armGroupLabels': ['Pemetrexed/Platinum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Cancer hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Chang jian hua, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer hospital Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy director of department of medical oncology', 'investigatorFullName': 'Chang Jian Hua', 'investigatorAffiliation': 'Fudan University'}}}}