Irinotecan Plus Cisplatin Compared With Etoposide Plus Cisplatin for Extensive Stage Small-cell Lung Cancer
- Registration Number
- NCT02348450
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 308
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Etoposide plus Cisplatin 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 plus Cisplatin Etoposide 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. Irinotecan plus Cisplatin 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 plus Cisplatin Irinotecan 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.
- Primary Outcome Measures
Name Time Method Progression free survival of first line therapy 24 months
- Secondary Outcome Measures
Name Time Method Objective Response Rate 24 months Number of patients experience adverse events 36 months Progression free survival of second line therapy 24 months Overall survival 36 months
Trial Locations
- Locations (20)
WuHan Tongji Hospital
🇨🇳WuHan, Hubei, China
LiaoNing Provincial Tumor Hospital
🇨🇳Shenyang, Liaoning, China
The second affiliated hospital of zhejiang university school of medicine
🇨🇳Hangzhou, Zhejiang, China
Linyi cancer hospital
🇨🇳Linyi, Shandong, China
Changhai Hospital of Shanghai
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of AnHui Medical University
🇨🇳Hefei, Anhui, China
FuJian Provincial Tumor Hospital
🇨🇳Fuzhou, Fujian, 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
Guangdong General Hospital
🇨🇳Guangzhou, Guangdong, China
HeNan Provincial Tumor Hospital
🇨🇳Zhengzhou, Henan, China
HuNan Provincial Tumor Hospital
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of NanChang University
🇨🇳Nanchang, Jiangxi, China
ShanDong Provincial Tumor Hospital
🇨🇳Jinan, Shandong, China
East Hospital Affiliated To Tongji University
🇨🇳Shanghai, Shanghai, China
Shanghai Chest hospital of Shanghai Jiaotong University
🇨🇳Shanghai, Shanghai, China
JiangSu Provincial Tumor Hospital
🇨🇳Nanjing, Jiangsu, China
ZheJiang Provincial Tumor Hospital
🇨🇳Hangzhou, Zhejiang, China
Hangzhou First People's Hospital
🇨🇳Hangzhou, Zhejiang, China