Solitary lung tumor within 3 years after complete resection of non-small cell lung cancer: patients with medically inoperable or refusing surgery: small lung lesion with the diameter of 3 cm or less
Conditions
Interventions
Stereotactic body radiation therapy 42 Gy/4 fractions
Sponsors
Japanese Radiation Oncology Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Lung lesion with the diameter of 3 cm or less 2. Within 3 years after complete resection of non-small cell lung cancer (NSCLC) 3. Fulfilling the following conditions i) or ii) plus iii) i) Histologically or cytologically confirmed NSCLC ii) Fulfilling both of the following conditions and clinically diagnosed as NSCLC a) Increase in tumor size of 1 mm or more, or consolidation/tumor ratio turning > 50% from <= 50% on CT scans performed 28 days or more apart b) Positive accumulation on FDG-PET/PET-CT iii) Small cell lung cancer is excluded 4. Without lymph node metastasis and extrapulmonary metastasis with chest CT, FDG-PET/PET-CT, and enhanced cranial MRI 5. No lesion suspected of malignant tumor excluding pure-GGO 6. Aged 20-90 years old 7. ECOG performance status of 0-2 8. Fulfilling the dose constraints on radiation treatment planning 9. No previous thoracic radiotherapy for ipsilateral lung 10. Diagnosed as inoperable by board certified respiratory surgeon or refusing surgery 11. Sufficient organ functions; fulfilling all of the following conditions; i) White blood cell >= 2000/mm3 ii) Hemoglobin >= 8.0 g/dL iii) Platelet >= 30000/mm3 iv) Total bilirubin <= 2.0 mg/dL v) Serum creatinine <= 2.0 mg/dL vi) FEV1.0 >= 700 mL vii) SpO2 (room air) >= 90% 12. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Lung lesion diagnosed as small cell lung cancer or large cell neuroendocrine cancer 2. Synchronous or metachronous malignancy within 3 years 3. Active infection requiring systemic therapy 4. Body temperature of 38 or more degrees Celsius 5. Woman during pregnancy or possible pregnancy, within 28 days after delivery, or during breast-feeding 6. Severe mental disease 7. Receiving continuous systemic steroid (more than 10mg/day of prednisolone) or immune-suppressive medication 8. Idiopathic pulmonary fibrosis on CT 9. Severe cough requiring narcortic drugs 10. Inappropriate patients for this study judged by physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, local progression-free survival, patterns of failure, local control period, early and late adverse events, severe adverse events | — |
Countries
Japan
Contacts
Public ContactShigeo Takahashi
Kagawa University Hospital Department of Radiation Oncology
Outcome results
None listed