Refractory relpased small-cell lung cancer
Conditions
Interventions
Amrubicin (40 mg/m2/day) on days 1 through 3, every 3 weeks
Sponsors
Japan Clinical Oncology Group(JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) histologically or cytologically confirmed small-cell lung cancer 2) received one or two prior chemotherapy or chemoradiotherapy with platinum-based regimen 3) no prior treatment with amrubicin 4) underwent no operation of small-cell lung cancer 5) no prior thoracic radiotherapy within 4 weeks 6) refractory or relapsed within 90 days of completing previous treatment 7) pathologically confirmed local relapse of small-cell lung cancer, if it was difficult to distinguish from radiation pneumonitis 8) performance status of 0-1 on the Eastern Cooperative Oncology Group scale 9) age from 20 to 74 years 10) measurable disease 11) adequate organ function 12) written informed consent
Exclusion criteria
Exclusion criteria: 1) active concomitant malignancy 2) active infection 3) fever 4) pregnancy or lactation 5) serious psychiatric illness 6) steroid treatment 7) massive pleural or pericardial effusion 8) symptomatic brain metastasis 9) interstitial pneumonia or severe pulmonary emphysema 10) ileus 11) myocardial infarction within 6 months or unstable angina 12) uncontrollable hypertension 13) uncontrollable diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, progression-free survival, adverse events | — |
Countries
Japan
Contacts
Public ContactHaruyasu Murakami
JCOG0901 Coordinating Office Shizuoka Cancer Center, Thoracic Oncology Division
Outcome results
None listed