non-small cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Histologically or cytologically confirmed Non small cell lung cancer 2. Unresectable or refusing surgery 3. Clinical stage IIB-IIIC (UICC 8th edition) 4. Aged 20-85 years old. 5. Eastern Cooperative Oncology Group(ECOG) performance status of 0-2. 6. No previous tehrapy, such as chemotherapy, surgery, radion therapy, immune therapy for lung cancer. 7. Sufficient organ functions; fulfilling all of the following conditions within 28 days; (i) White blood cell:3000/mm3 or more (ii) Hemoglobin:8.0 g/dl or more (iii) Platelet:50000/mm3 or more (iv) Total bilirubin:2.0 mg/dl or less (v) Serum creatinine:2.0 mg/dl or less (vi) FEV1.0:700 ml or more (vii) SpO2 (room air):90% or more 8. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Synchronous or metachronous (within 3 years) malignancies. 2. Active infection requiring systemic therapy. 3. Body temperature of 38 or more degrees Celsius. 4. Women during pregnancy or possible pregnancy, within 28 days after delivery, or during breast feeding. 5. Severe mental disease. 6. Receiving continuous systemic steroid or immune-suppressive medication. 7. Idiopathic pulmonary fibrosis on CT. 8. Severe cough requiring narcotic drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of Grade 3 or higher radiation pneumonitis(Common Terminology Criteria for Adverse Events ; CTCAE ver. 5.0) within 1 year after IMRT. | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, progression-free survival, Grade 3 or higher adverse effects other than radiation pneumonitis, the relationship between dose-volume histogram(DVH) parameters and Grad 2, 3 or higher radiation pneumonitis, pulmonary function at 1 year after IMRT | — |
Countries
Japan
Contacts
Hiroshima University Hospital Radiation Oncology