extensive-disease small-cell lung cancer
Conditions
Interventions
A:Patients receive amrubicine on day 1 and irinotecan on days 1 and 8. Courses repeat every 3 weeks.
B:Patients receive cisplatin on day 1 and irinotecan on days 1, 8, and 15. Courses repeat every 4
Sponsors
The Japan-multinational Trial Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) histologically or cytologically proven small-cell lung cancer 2) extensive-stage small-cell lung cancer or limited-stage small-cell lung cancer with malignant pleural or pericardial effusion 3) no prior chemotherapy 4) performance status of 0 to 2 5) predicted life expectancy of 3 months 6) patients who has received palliative radiotherapy for brain or bone metastases can be included 7) adequate organ functions 8) measurable or unmeasurable disease 9) age 20 years or older 10) written informed consent
Exclusion criteria
Exclusion criteria: 1)uncontrollable pleural, pericardial effusion or ascites 2)uncontrolled heart disease 3)uncontrolled diabetes mellitus 4)active infection 5)radiotherapy including pulmonary field 6)interstitial pneumonia/active lung fibrosis on chest x-ray 7)patients who has been taking steroid or immunosuppressant for any other disease 8)watery diarrhea, intestinal paralysis or obstruction 9)history of severe drug allergy 10)active concomitant malignancy 11)pregnant or lactating woman 12)patients whose participation in the trial is judged to be inappropriate by the attending doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival (1-year survival rate) | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival response rate safety (incidence of an adverse event) | — |
Countries
Japan
Contacts
Public ContactSaori Kato
The Japan-multinational Trial Organization The Japan-multinational Trial Organization datacenter
Outcome results
None listed