Small cell lung cancer
Conditions
Interventions
Prediction by TDM/uncontrolled
Sponsors
Saitama Medical University
National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with histologically or cytologically diagnosed small cell lung cancer. (2) Patients who have received platinum-based chemotherapy and are scheduled for treatment with amrubicin hydrochloride. (3) Patients aged 20 years or older at the time of consent acquisition. 4) ECOG performance status of 0 or 1 at the time of enrollment 5) Body surface area less than 2.0 m2 immediately before enrollment (up to 2 weeks before the start of treatment) (6) Patients who can understand the explanation and consent documents for this clinical trial and have obtained written consent from the patient.
Exclusion criteria
Exclusion criteria: (1) Patients who have received treatment with amrubicin hydrochloride in the past. 2) Patients who require concomitant use of other anticancer drugs, immunotherapy, or concomitant use of thoracic irradiation. (3) Patients who have received anticancer drugs (excluding immune check inhibitors) within 3 weeks prior to enrollment or within 5 times the half-life of other therapies, whichever is shorter, or who have not recovered from the toxicity of these previous therapies (grade 1 or up to baseline). (4) Patients who have not recovered from the toxicity of radiation or major surgery performed prior to the start of enrollment (Grade 1 or baseline). (5) Patients with symptomatic unstable brain metastasis or central nervous system invasion (6) Patients currently participating in other clinical trials. (6) Patients currently participating in other clinical trials, but not excluded if they are undergoing follow-up after the completion of the trial or if participation in this clinical trial is permitted in the relevant trial. (7) Female patients who may be pregnant, or pregnant or lactating women. (8) Active infectious diseases requiring systemic administration of antimicrobial agents (prophylactic administration is not excluded) Fluid retention (pleural effusion, pericardial effusion) that requires puncture and drainage within 14 days prior to enrollment and continuous treatment after the procedure Poorly controlled heart failure, coronary artery disease, arrhythmia, arteriovenous thrombosis, cerebral infarction, diabetes mellitus, autoimmune disease, psychiatric symptoms Complications of interstitial pneumonia or pulmonary fibrosis evident on chest x-ray (including pre-existing conditions) (9) COVID-19 positive patients (10) HIV-positive patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of FN expression in the first course of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of severe neutropenia in the first course of treatment Relative Dose Intensity (RDI) Progression-free survival Overall survival Cost-effectiveness | — |
Countries
Japan
Contacts
Public ContactYoshinori Makino
Saitama Medical University International Medical Center Cancer Genome Medicine / Pharmacy
Outcome results
None listed