Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-02-25 @ 8:25 PM
Study NCT ID:
NCT00563160
Status:
UNKNOWN
Last Update Posted:
2010-07-07
First Post:
2007-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Efficacy of Induction Chemotherapy With Gemcitabine and Carboplatin for Operable Non-small-cell Lung Cancer Before Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'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': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2007-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-07-06', 'studyFirstSubmitDate': '2007-11-21', 'studyFirstSubmitQcDate': '2007-11-23', 'lastUpdatePostDateStruct': {'date': '2010-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pathological response rate', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'progression-free survival', 'timeFrame': '18 months'}, {'measure': 'overall survival', 'timeFrame': '18 months'}, {'measure': 'quality of life measurements', 'timeFrame': '18 months'}]}, 'conditionsModule': {'keywords': ['lung cancer'], 'conditions': ['Lung Neoplasms']}, 'descriptionModule': {'briefSummary': 'To study the activity of chemotherapy with Gemzar-carboplatin in the preoperative setting for operable stages of non-small-cell lung cancer and to identify novel molecular markers correlated with chemosensitivity and prognosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically proven, newly diagnosed primary bronchogenic non-small cell lung cancer\n* Measurable or evaluable tumour on chest X-ray or CT scan.\n* No multiple ipsilateral or contralateral parenchymal tumours\n* Stage I(exceptT1N0),II,IIIa disease as shown by PET-CT'}, 'identificationModule': {'nctId': 'NCT00563160', 'briefTitle': 'Study of Efficacy of Induction Chemotherapy With Gemcitabine and Carboplatin for Operable Non-small-cell Lung Cancer Before Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hospital Authority, Hong Kong'}, 'officialTitle': 'Phase II Study of the Response Rate of Induction Chemotherapy With Gemcitabine and Carboplatin for Operable Non-small Cell Lung Cancer Before Surgery', 'orgStudyIdInfo': {'id': '(193-h)in QE/EC/I'}, 'secondaryIdInfos': [{'id': 'HARECCTR0500015'}, {'id': '000904'}, {'id': 'B9E-IH-O333'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'gemcitabine, carboplatin', 'type': 'DRUG'}, {'name': 'surgery', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Che Mun Poon, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chun Key Law, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Roger Ngan, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chung Kong Kwan, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cheuk Kin Lo, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Johnny Chan, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'TK Au Yong, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ting Lok Kwan, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stella Cheung, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Timothy Yip', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Patricia Poon, Dr', 'role': 'CONTACT', 'email': 'pcm0806@netvigator.com', 'phone': '(852) 2958 2310'}], 'overallOfficials': [{'name': 'Siu Kie Au, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Oncology, Queen Elizabeth Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Authority, Hong Kong', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}]}}}