Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT02348450
Status:
UNKNOWN
Last Update Posted:
2016-12-05
First Post:
2014-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Irinotecan Plus Cisplatin Compared With Etoposide Plus Cisplatin for Extensive Stage Small-cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 308}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-02', 'studyFirstSubmitDate': '2014-10-23', 'studyFirstSubmitQcDate': '2015-01-22', 'lastUpdatePostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival of first line therapy', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '36 months'}, {'measure': 'Objective Response Rate', 'timeFrame': '24 months'}, {'measure': 'Number of patients experience adverse events', 'timeFrame': '36 months'}, {'measure': 'Progression free survival of second line therapy', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This study is aimed to evaluate the progression-free survival(PFS) and also survival of IP and EP (head-to-head) as the first line therapy for extensive stage small-cell lung cancer and to explore the reasonable first-line therapy for Chinese population. An open-label, multi-center study will be conducted with dynamic randomization of approximately 1:1 ratio with an estimation of 308 eligible participants.', 'detailedDescription': 'evaluate the progression-free survival(PFS) and also survival of IP and EP (head-to-head) as the first line therapy for extensive stage small-cell lung cancer and to explore the reasonable first-line therapy for Chinese population.\n\nAn open-label, multi-center study will be conducted with dynamic randomization of approximately 1:1 ratio with an estimation of 308 eligible participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Cytologically or histologically confirmed extensive stage small-cell lung cancer (remote metastasis and/or contralateral lymph-node involvement; not those with simple ipsilateral pleural effusion);\n* No prior radiotherapy, chemotherapy or surgery;\n* At least one measurable lesion, CT≥20mm, spiral CT≥10mm(diameter);\n* ECOG PS 0-1;\n* Age 18-70;\n* Life expectancy \\> three months;\n* In general normal function of heart, liver, kidney and bone marrow;\n* WBC C\\>4.0×10(9)/L, NEUT\\>1.50×10(9)/L, PLT\\>100×10(9)/L, Hb\\>95g/L;\n* Liver function: TBIL \\< 1.5 x UL normal range; ALT and AST \\< 1.5 x UL normal range;\n* Kidney function: normal serum creatinine level;\n* Signed an informed consent and will comply with the study protocol and follow-up plans.\n\nExclusion Criteria:\n\n* Failed to meet the entry criteria of pathology and clinical stage;\n* Have received prior chemotherapy or target treatment;\n* Currently receiving other anticancer therapy;\n* No measurable lesions or lesions cannot be assessed;\n* Patients with acute or chronic medical or psychiatric condition, or laboratory abnormalities that may impact the judgment of the investigator and the result of the study, determined by investigator they may include:\n\nUncontrolled tumor metastasis in central nerve system; Uncontrolled hypertension, unstable angina, MI history, or congestive heart-failure, uncontrolled arrhythmia, ischemic vascular disease within the 12 months prior to study treatment; Myocardial ischemia by ECG or valvular heart disease; Grade 3 or above peripheral neuropathy; Active stage of infection by bacteria, fungi or virus; Pregnant or breast feeding woman; History of uncontrolled mental disease.\n\n* Not able to discontinue NSAIDs treatment;\n* Other active malignant tumors except non-melanoma skin cancer, in-situ cervical carcinoma and cured early prostatic carcinoma;\n* Patients with allergies, known or may be allergic to drugs in research;\n* Patients with poor compliance to treatment and follow-up;\n* Patients with UGT1A1-6 and UGT1A1-28 gene mutation;\n* With clinical symptoms of brain metastasis(patient with stable clinical performance and no need to treat can be included in the trial);\n* Chest, abdominal or pericardial effusion that needs anti-cancer intervention;\n* Accompanied with Grade ≥2 diarrhea;\n* Participated in other clinical trials within one month before randomization;\n* Investigator's judgment to exclude."}, 'identificationModule': {'nctId': 'NCT02348450', 'briefTitle': 'Irinotecan Plus Cisplatin Compared With Etoposide Plus Cisplatin for Extensive Stage Small-cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Guangdong Association of Clinical Trials'}, 'officialTitle': 'Irinotecan Plus Cisplatin Compared With Etoposide Plus Cisplatin for Extensive Stage Small-cell Lung Cancer: a Multi-center, Randomized, Open Label Study', 'orgStudyIdInfo': {'id': 'CTONG1404'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Irinotecan plus Cisplatin', 'description': "first line: irinotecan 65mg/m2 d1,8. Cisplatin 30mg/m2，d1,8, 21days/cycle×6 cycles Second-line: etoposide alone OR etoposide plus cisplatin, dosage will be same as first line or on investigator's discretion.", 'interventionNames': ['Drug: Irinotecan', 'Drug: Cisplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Etoposide plus Cisplatin', 'description': "first line: etoposide 60mg/m2 d1-5 Cisplatin 75mg/m2，d1(recommended), or administer three times with same total daily dose , 21days/cycle×6 cycles Second-line: irinotecan alone or irinotecan plus cisplatin, dosage is same as first line or on investigator's discretion.", 'interventionNames': ['Drug: Etoposide', 'Drug: Cisplatin']}], 'interventions': [{'name': 'Irinotecan', 'type': 'DRUG', 'otherNames': ['Ai Li'], 'description': '40mg', 'armGroupLabels': ['Irinotecan plus Cisplatin']}, {'name': 'Etoposide', 'type': 'DRUG', 'otherNames': ['H32025583'], 'description': '5ml：0.1g', 'armGroupLabels': ['Etoposide plus Cisplatin']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['Nuo Xin'], 'description': '6ml：30mg', 'armGroupLabels': ['Etoposide plus Cisplatin', 'Irinotecan plus Cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yueyin pan', 'role': 'CONTACT', 'email': 'yueyinpan@gmail.com', 'phone': '86-13805695536'}, {'name': 'wei huang', 'role': 'CONTACT', 'email': 'huangweibsh@163.com', 'phone': '86-13505514938'}], 'facility': 'The First Affiliated Hospital of AnHui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Fuzhou', 'state': 'Fujian', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'cheng huang', 'role': 'CONTACT', 'email': 'cheng671@sina.com', 'phone': '13905010379'}], 'facility': 'FuJian Provincial Tumor Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Guangdong General Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Nanning', 'state': 'Guangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xiangqun song', 'role': 'CONTACT', 'email': 'xiangquns@163.com', 'phone': '86-13877104657'}, {'name': 'shaozhang zhou', 'role': 'CONTACT', 'email': 'zhoushaozhang@qq.com', 'phone': '86-18677115144'}], 'facility': 'Cancer Hospital Affiliated To GuangXi Medical University', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'cuimin ding', 'role': 'CONTACT', 'email': 'wjwdcm@sina.com', 'phone': '86-13933083069'}, {'name': 'ruijuan li', 'role': 'CONTACT', 'email': 'lrj0310@sina.com', 'phone': '86-18231196950'}], 'facility': 'Fourth hospital of hebei medical university', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Haerbin', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'gongyan chen', 'role': 'CONTACT'}, {'name': 'xuan hong', 'role': 'CONTACT', 'email': 'hongxuan_1218@sina.com', 'phone': '13946066560'}], 'facility': 'The First Affiliated Hospital of HaErBin Medical University'}, {'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'zhiyong Ma', 'role': 'CONTACT'}, {'name': 'xiangtao Yan', 'role': 'CONTACT', 'email': 'skyliuyun@126.com', 'phone': '18638628118'}], 'facility': 'HeNan Provincial Tumor Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yuan chen', 'role': 'CONTACT'}, {'name': 'qian chu', 'role': 'CONTACT', 'email': 'qianchu@tjh.tjmu.edu.cn'}], 'facility': 'WuHan Tongji Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jianhua chen', 'role': 'CONTACT'}, {'name': 'yongzhong luo', 'role': 'CONTACT', 'email': '65523714@qq.com', 'phone': '13607443876'}], 'facility': 'HuNan Provincial Tumor Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'meiqi shi', 'role': 'CONTACT', 'email': 'shimeiqi1963@163.com', 'phone': '13809029766'}], 'facility': 'JiangSu Provincial Tumor Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'The First Affiliated Hospital of NanChang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Shenyang', 'state': 'Liaoning', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'LiaoNing Provincial Tumor Hospital', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'qisen guo', 'role': 'CONTACT'}, {'name': 'yan guan', 'role': 'CONTACT', 'email': 'qhgy219@163.com', 'phone': '15865298279'}], 'facility': 'ShanDong Provincial Tumor Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Linyi', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jianhua shi', 'role': 'CONTACT', 'email': 'shijianhualy@126.com', 'phone': '86-15963998868'}, {'name': 'shuoxin liu', 'role': 'CONTACT', 'email': 'lyzlyygcp@163.com', 'phone': '86-15969916696'}], 'facility': 'Linyi cancer hospital', 'geoPoint': {'lat': 35.06306, 'lon': 118.34278}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'chong bai', 'role': 'CONTACT'}, {'name': 'huijie zhang', 'role': 'CONTACT', 'email': '15236196601@163.com', 'phone': '18621775835'}], 'facility': 'Changhai Hospital of Shanghai', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'East Hospital Affiliated To Tongji University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shun Lu, MD', 'role': 'CONTACT', 'email': 'shun_lu@hotmail.com', 'phone': '86 13601813062'}, {'name': 'Zhiwei Chen', 'role': 'CONTACT', 'email': 'drchenzhiwei@163.com', 'phone': '86 13916251926'}], 'facility': 'Shanghai Chest hospital of Shanghai Jiaotong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': "Hangzhou First People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'kai wang', 'role': 'CONTACT', 'email': 'doctorhuxi@163.com', 'phone': '86-13957158572'}, {'name': 'liren ding', 'role': 'CONTACT', 'email': 'lirending@zju.edu.cn', 'phone': '86-13906535702'}], 'facility': 'The second affiliated hospital of zhejiang university school of medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'ZheJiang Provincial Tumor Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Shun Lu, M.D', 'role': 'CONTACT', 'email': 'shun_lu@hotmail.com', 'phone': '86-13601813062'}, {'name': 'zhiwei Chen', 'role': 'CONTACT', 'email': 'drchenzhiwei@163.com', 'phone': '86-13916251926'}], 'overallOfficials': [{'name': 'Shun Lu, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Chest hospital of Shanghai Jiaotong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangdong Association of Clinical Trials', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}