Extensive-stage Small Cell Lung Cancer
Conditions
Brief summary
Patients with untreated extensive-stage small cell lung cancer(SCLC) were randomly assigned to receive either irinotecan/cisplatin (IP) or etoposide/cisplatin(EP), The association of efficacy and toxicity of IP regimen was analyzed.
Detailed description
This is a randomized, multicenter study. Patients are randomized to irinotecan/cisplatin (IP) or etoposide/cisplatin (EP) treatment arms. The IP regimen consisted of at most 6 cycles of irinotecan 65 mg/m2 of body-surface area on days 1, 8 and cisplatin 75mg/m2 of body-surface area on day 1. The EP regimen consisted of at most 6 cycles of etoposide 100 mg/m2 of body-surface area from day 1 to 3 and cisplatin 75mg/m2 of body-surface area on day 1. Cycle length for the two arms was 3 weeks. The dose adjustment was allowed in at most within ±5% per investigator discretion if necessary.
Interventions
Sponsors
China-Japan Friendship Hospital
Chinese PLA General Hospital
Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) of 0 to 2 * A life expectancy of at least 3 months * Measurable lesions * Adequate hematologic function
Exclusion criteria
* Infection * Myocardial infarction within the preceding three months * Symptomatic brain metastases or receiving radiotherapy less than 4 weeks * Pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival | 1 month |
Countries
China
Outcome results
None listed