Non-small-cell lung cancer
Conditions
Interventions
Carboplatin plus nab-Paclitaxel with concurrent thoracic radiotherapy
Sponsors
Shizuoka cancer center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Cytologically or histologically confirmed non-small-cell lung cancer 2)Unresectable locally advanced non-small-cell lung cancer (stage III) 3)When radio-oncologist judged that the patients can tolerable for full dose irradiation 4)No prior chemotherapy and thoracic radiotherapy 5)At least one measurable lesion 6)Aged 75 or more 7)ECOG Performance status of 0-1 8)Sufficient major organ function 9)Life expectancy of at least 90 days 10)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Active double cancer 2)History of severe infections or complications 3)HBs antigen positive 4)History of thoracic radiotherapy 5)Radiographically (chest CT image) confirmed interstitial pneumonitis or pulmonary fibrosis 6)Severe emphysema, chronic bronchitis, asthma 7)History of drug-induced pneumonia or severe drug allergies 8)Uncontrolled diabetes despite continuing treatment of insulin 9)Unstable angina, cardiac infarction within 6 months before enrollment 10)Obvious abnormality of the electrocardiogram 11)Grade 2 or higher peripheral neuropathy 12)A fever of over 38 degrees 13)Continuous systemic administration of steroid or immunosuppressant 14)Patients with severe mental illness 15)Unsuitable patients judged by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose escalation part: The incidence of dose limiting toxicity Expansion part: The ratio of patients who completed the prescribed treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose escalation part: Safety, Response rate, Progression free survival Expansion part: Response rate, Progression free survival, 2 years survival rate | — |
Countries
Japan
Contacts
Public ContactShota Omori
Shizuoka cancer center Division of Thoracic Oncology
Outcome results
None listed