Advanced squamous cell lung cancer in elderly patients
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically proven squamous cell lung cancer 2) Stage IV or stage III without any indications for radiotherapy 3) No prior chemotherapy 4) ECOG performance status 0-1 5) Measurable disease (RECIST ver.1.1) 6) Aged >=75 7) Adequate organ function 8) Estimated life expectancy at least 3 months 9) Written informed consent by patient
Exclusion criteria
Exclusion criteria: 1) Active multiple malignancy 2) History of hypersensitivity for albumin products 3) Severe drug allergy 4) Within 2 weeks after palliative radiotherapy 5) Uncontrolled symptomatic brain metastasis 6) Uncontrolled pleural effusion, ascites, and pericardial effusion which needs drainage 7) Uncontrollable ulcer of digestive tract or diabetes 8) Interstitial pneumonia 9) Psychiatric disease or symptoms, who seem to have difficulty in participating in the study 10) Other severe complications 11) Judged to be not suitable by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| <Phase I portion> To determine the recommended dose <Phase II portion> Progression-free survival rate at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) Progression-free survival (PFS) Response rate(RR) Rate of adverse events | — |
Countries
Japan
Contacts
National Cancer Center Hospital East Department of Thoracic Oncology