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Irinotecan Plus Cisplatin Compared With Etoposide Plus Cisplatin for Extensive Stage Small-cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT02348450
Recruitment Status : Unknown
Verified December 2016 by Guangdong Association of Clinical Trials.
Recruitment status was:  Recruiting
First Posted : January 28, 2015
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
Guangdong Association of Clinical Trials

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Irinotecan Drug: Etoposide Drug: Cisplatin Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Irinotecan Plus Cisplatin Compared With Etoposide Plus Cisplatin for Extensive Stage Small-cell Lung Cancer: a Multi-center, Randomized, Open Label Study
Study Start Date : February 2015
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Irinotecan plus Cisplatin
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.
Drug: Irinotecan
40mg
Other Name: Ai Li

Drug: Cisplatin
6ml:30mg
Other Name: Nuo Xin

Experimental: Etoposide plus Cisplatin
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.
Drug: Etoposide
5ml:0.1g
Other Name: H32025583

Drug: Cisplatin
6ml:30mg
Other Name: Nuo Xin




Primary Outcome Measures :
  1. Progression free survival of first line therapy [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 36 months ]
  2. Objective Response Rate [ Time Frame: 24 months ]
  3. Number of patients experience adverse events [ Time Frame: 36 months ]
  4. Progression free survival of second line therapy [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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);
  • No prior radiotherapy, chemotherapy or surgery;
  • At least one measurable lesion, CT≥20mm, spiral CT≥10mm(diameter);
  • ECOG PS 0-1;
  • Age 18-70;
  • Life expectancy > three months;
  • In general normal function of heart, liver, kidney and bone marrow;
  • WBC C>4.0×10(9)/L, NEUT>1.50×10(9)/L, PLT>100×10(9)/L, Hb>95g/L;
  • Liver function: TBIL < 1.5 x UL normal range; ALT and AST < 1.5 x UL normal range;
  • Kidney function: normal serum creatinine level;
  • Signed an informed consent and will comply with the study protocol and follow-up plans.

Exclusion Criteria:

  • Failed to meet the entry criteria of pathology and clinical stage;
  • Have received prior chemotherapy or target treatment;
  • Currently receiving other anticancer therapy;
  • No measurable lesions or lesions cannot be assessed;
  • 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:

Uncontrolled 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.

  • Not able to discontinue NSAIDs treatment;
  • Other active malignant tumors except non-melanoma skin cancer, in-situ cervical carcinoma and cured early prostatic carcinoma;
  • Patients with allergies, known or may be allergic to drugs in research;
  • Patients with poor compliance to treatment and follow-up;
  • Patients with UGT1A1-6 and UGT1A1-28 gene mutation;
  • With clinical symptoms of brain metastasis(patient with stable clinical performance and no need to treat can be included in the trial);
  • Chest, abdominal or pericardial effusion that needs anti-cancer intervention;
  • Accompanied with Grade ≥2 diarrhea;
  • Participated in other clinical trials within one month before randomization;
  • Investigator's judgment to exclude.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348450


Contacts
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Contact: Shun Lu, M.D 86-13601813062 shun_lu@hotmail.com
Contact: zhiwei Chen 86-13916251926 drchenzhiwei@163.com

Locations
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China, Anhui
The First Affiliated Hospital of AnHui Medical University Recruiting
Hefei, Anhui, China
Contact: yueyin pan    86-13805695536    yueyinpan@gmail.com   
Contact: wei huang    86-13505514938    huangweibsh@163.com   
China, Fujian
FuJian Provincial Tumor Hospital Not yet recruiting
Fuzhou, Fujian, China
Contact: cheng huang    13905010379    cheng671@sina.com   
China, Guangdong
Guangdong General Hospital Active, not recruiting
Guangzhou, Guangdong, China
China, Guangxi
Cancer Hospital Affiliated To GuangXi Medical University Recruiting
Nanning, Guangxi, China
Contact: xiangqun song    86-13877104657    xiangquns@163.com   
Contact: shaozhang zhou    86-18677115144    zhoushaozhang@qq.com   
China, Hebei
Fourth hospital of hebei medical university Recruiting
Shijiazhuang, Hebei, China
Contact: cuimin ding    86-13933083069    wjwdcm@sina.com   
Contact: ruijuan li    86-18231196950    lrj0310@sina.com   
China, Heilongjiang
The First Affiliated Hospital of HaErBin Medical University Recruiting
Haerbin, Heilongjiang, China
Contact: gongyan chen         
Contact: xuan hong    13946066560    hongxuan_1218@sina.com   
China, Henan
HeNan Provincial Tumor Hospital Recruiting
Zhengzhou, Henan, China
Contact: zhiyong Ma         
Contact: xiangtao Yan    18638628118    skyliuyun@126.com   
China, Hubei
WuHan Tongji Hospital Recruiting
WuHan, Hubei, China
Contact: yuan chen         
Contact: qian chu       qianchu@tjh.tjmu.edu.cn   
China, Hunan
HuNan Provincial Tumor Hospital Recruiting
Changsha, Hunan, China
Contact: jianhua chen         
Contact: yongzhong luo    13607443876    65523714@qq.com   
China, Jiangsu
JiangSu Provincial Tumor Hospital Recruiting
Nanjing, Jiangsu, China
Contact: meiqi shi    13809029766    shimeiqi1963@163.com   
China, Jiangxi
The First Affiliated Hospital of NanChang University Active, not recruiting
Nanchang, Jiangxi, China
China, Liaoning
LiaoNing Provincial Tumor Hospital Active, not recruiting
Shenyang, Liaoning, China
China, Shandong
ShanDong Provincial Tumor Hospital Recruiting
Jinan, Shandong, China
Contact: qisen guo         
Contact: yan guan    15865298279    qhgy219@163.com   
Linyi cancer hospital Recruiting
Linyi, Shandong, China
Contact: jianhua shi    86-15963998868    shijianhualy@126.com   
Contact: shuoxin liu    86-15969916696    lyzlyygcp@163.com   
China, Shanghai
Changhai Hospital of Shanghai Recruiting
Shanghai, Shanghai, China
Contact: chong bai         
Contact: huijie zhang    18621775835    15236196601@163.com   
East Hospital Affiliated To Tongji University Active, not recruiting
Shanghai, Shanghai, China
Shanghai Chest hospital of Shanghai Jiaotong University Recruiting
Shanghai, Shanghai, China
Contact: Shun Lu, MD    86 13601813062    shun_lu@hotmail.com   
Contact: Zhiwei Chen    86 13916251926    drchenzhiwei@163.com   
China, Zhejiang
Hangzhou First People's Hospital Active, not recruiting
Hangzhou, Zhejiang, China
The second affiliated hospital of zhejiang university school of medicine Recruiting
Hangzhou, Zhejiang, China
Contact: kai wang    86-13957158572    doctorhuxi@163.com   
Contact: liren ding    86-13906535702    lirending@zju.edu.cn   
ZheJiang Provincial Tumor Hospital Active, not recruiting
Hangzhou, Zhejiang, China
Sponsors and Collaborators
Guangdong Association of Clinical Trials
Investigators
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Principal Investigator: Shun Lu, M.D Shanghai Chest hospital of Shanghai Jiaotong University

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Responsible Party: Guangdong Association of Clinical Trials
ClinicalTrials.gov Identifier: NCT02348450     History of Changes
Other Study ID Numbers: CTONG1404
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cisplatin
Irinotecan
Etoposide
Etoposide phosphate
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors