Irinotecan Plus Cisplatin Compared With Etoposide Plus Cisplatin for Extensive Stage Small-cell Lung Cancer
1 other identifier
interventional
308
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2015
Longer than P75 for phase_4
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2014
CompletedFirst Posted
Study publicly available on registry
January 28, 2015
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedDecember 5, 2016
December 1, 2016
2 years
October 23, 2014
December 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival of first line therapy
24 months
Secondary Outcomes (4)
Overall survival
36 months
Objective Response Rate
24 months
Number of patients experience adverse events
36 months
Progression free survival of second line therapy
24 months
Study Arms (2)
Irinotecan plus Cisplatin
EXPERIMENTALfirst 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.
Etoposide plus Cisplatin
EXPERIMENTALfirst 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shun Lu, M.D
Shanghai Chest hospital of Shanghai Jiaotong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2014
First Posted
January 28, 2015
Study Start
February 1, 2015
Primary Completion
February 1, 2017
Study Completion
December 1, 2018
Last Updated
December 5, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share