Irinotecan Plus Cisplatin Compared With Etoposide Plus Cisplatin for Extensive Stage Small-cell Lung Cancer
NCT ID: NCT02348450
Last Updated: 2016-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
308 participants
INTERVENTIONAL
2015-02-28
2018-12-31
Brief Summary
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Detailed Description
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An open-label, multi-center study will be conducted with dynamic randomization of approximately 1:1 ratio with an estimation of 308 eligible participants.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Irinotecan
40mg
Cisplatin
6ml：30mg
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.
Etoposide
5ml：0.1g
Cisplatin
6ml：30mg
Interventions
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Irinotecan
40mg
Etoposide
5ml：0.1g
Cisplatin
6ml：30mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Guangdong Association of Clinical Trials
OTHER
Responsible Party
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Principal Investigators
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Shun Lu, M.D
Role: PRINCIPAL_INVESTIGATOR
Shanghai Chest hospital of Shanghai Jiaotong University
Locations
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The First Affiliated Hospital of AnHui Medical University
Hefei, Anhui, China
FuJian Provincial Tumor Hospital
Fuzhou, Fujian, China
Guangdong General Hospital
Guangzhou, Guangdong, China
Cancer Hospital Affiliated To GuangXi Medical University
Nanning, Guangxi, China
Fourth hospital of hebei medical university
Shijiazhuang, Hebei, China
The First Affiliated Hospital of HaErBin Medical University
Haerbin, Heilongjiang, China
HeNan Provincial Tumor Hospital
Zhengzhou, Henan, China
WuHan Tongji Hospital
Wuhan, Hubei, China
HuNan Provincial Tumor Hospital
Changsha, Hunan, China
JiangSu Provincial Tumor Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of NanChang University
Nanchang, Jiangxi, China
LiaoNing Provincial Tumor Hospital
Shenyang, Liaoning, China
ShanDong Provincial Tumor Hospital
Jinan, Shandong, China
Linyi cancer hospital
Linyi, Shandong, China
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, China
East Hospital Affiliated To Tongji University
Shanghai, Shanghai Municipality, China
Shanghai Chest hospital of Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
The second affiliated hospital of zhejiang university school of medicine
Hangzhou, Zhejiang, China
ZheJiang Provincial Tumor Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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yueyin pan
Role: primary
wei huang
Role: backup
cheng huang
Role: primary
xiangqun song
Role: primary
shaozhang zhou
Role: backup
cuimin ding
Role: primary
ruijuan li
Role: backup
gongyan chen
Role: primary
xuan hong
Role: backup
zhiyong Ma
Role: primary
xiangtao Yan
Role: backup
yuan chen
Role: primary
qian chu
Role: backup
jianhua chen
Role: primary
yongzhong luo
Role: backup
meiqi shi
Role: primary
qisen guo
Role: primary
yan guan
Role: backup
jianhua shi
Role: primary
shuoxin liu
Role: backup
chong bai
Role: primary
huijie zhang
Role: backup
Shun Lu, MD
Role: primary
Zhiwei Chen
Role: backup
kai wang
Role: primary
liren ding
Role: backup
Other Identifiers
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CTONG1404
Identifier Type: -
Identifier Source: org_study_id