medically inoperable stage IA non-small cell lung cancer or small lung lesion (tumor diameter within 3cm) clinically diagnosed as primary lung cancer
Conditions
Interventions
A: stereotactic body radiotherapy 42 Gy/4 fractions
B: stereotactic body radiotherapy 55 Gy/4 fractions
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Fulfilling the following conditions i) or ii) plus iii), and diagnosed with non-small cell lung cancer (NSCLC). 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. iii) Small cell lung cancer is excluded. 2.Clinical T1N0M0 (c-stage IA) or small lung lesions (tumor diameter within 3 cm) clinically diagnosed as primary lung cancer with chest X-ray, enhanced chest and upper abdominal CT, enhanced cranial MRI, and FDG-PETwithin 56 days. 3. No lesions suspected of malignant tumor excluding non-invasive cancers (tumor diameter within 2cm and C/T ratio within 0.25) on imaging in the thorax other than primary lesion. 4. Aged 20-90 years old. 5. ECOG performance status of 0-2. 6. No previous thoracic radiotherapy. Previous radiations to contralateral breast and chest wall after surgery of breast cancers are allowed if they fulfill either of the following conditions. a) No overlap of radiation fields b) The total skin maximum dose (D2%) <= 70 Gy 7. Diagnosed as inoperable by respiratory surgeons or refusing surgery. 8. Fulfilling the dose constraints in 55 Gy in 4 fractions on radiation treatment planning. 9. Sufficient organ functions; fulfilling all of the following conditions within 28 days; i) White blood cell >=2,000/mm3 ii) Hemoglobin >= 8.0 g/dL iii) Platelet >= 3.0*104 / 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% 10. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Synchronous or metachronous (within 5 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 narcortic drugs.
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, serious adverse events | — |
Countries
Japan
Contacts
Public ContactTomoki Kimura
JCOG1408 Coordinating Office Department of Radiation Oncology, Hiroshima University Hospital
Outcome results
None listed