Extensive stage small cell lung cancer
Conditions
Interventions
Sponsors
Third department of internal medicine, Universtiy of Fukui
Japanese Red Cross Fukui Hospital, Municipal Tsuruga Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically or cytologically confirmed extensive stage small cell lung cancer (SCLC). 2) Patients who received immunotherapy in combination with chemotherapy for their first line treatment. 3) Within 8 weeks after end of first line treatment. 4) Patient with evaluable lesion based on RECIST. 5) Age 20 or over. 6) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 7) No severe organ dysfunction and laboratory data fulfill the standards. 8) Three months and more survival is expected. 9) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients who previously treated with irinotecan 2) Patients with homozygous polymorphisms for UGT1A1*28 and *6 (*28/*28, *6/*6, and *6/*28) 3) Diarrhea (grade 1 or more) before the treatment. 4) Uncontrolable pleural or pericardial effusion. 5) Within 2 weeks after radiotherapy. 6) Operation within 4 weeks. 7) Active double cancer. 8) Active infectious disease. 9) Severe complications including heart failure, hepatic failure, renal failure, paresis of intestine, and ileus. 10) Pregnant woman. 11) HBs antigen positive. 12) Patients who received systemic corticosteroid (10mg or more prednisolone conversion). 13) The subjects whom the doctor excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, disease control rate, overall survival, and safety. Subset analysis of efficacy stratified by smoking history and objective response of previous treatment. | — |
Countries
Japan
Contacts
Public ContactYukihiro Umeda
University of Fukui Third department of internal medicine
Outcome results
None listed