T1N0M0 Non-small Cell Lung Cancer
Conditions
Keywords
stereotactic body radiation therapy, T1N0M0 non-small cell lung cancer, radiotherapy
Brief summary
To evaluate the efficacy and safety of SBRT for T1N0M0 non-small cell lung cancer
Detailed description
To evaluate the efficacy and safety of SBRT for T1N0M0 non-small cell lung cancer，the following questions should be answered. Can SRT be an alternative standard treatment modality for inoperable patients? Can SRT can be a comparable standard treatment modality with lobectomy for operable patients? 12 Gy is the daily dose at the isocenter，and 48 Gy in total by 4 fractions will be irradiated by stereotactic irradiation over 4 to 8 days.
Interventions
PROCEDUREstereotactic body radiation therapy
Procedure/Surgery: stereotactic body radiation therapy
Sponsors
Ministry of Health, Labour and Welfare, Japan
Haruhiko Fukuda
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically or transbronchoscopic cytologically confirmed non-small cell lung cancer 2. Stage IA with images within 28 days 3. No other intrathoracic lesions 4. Dose constraints of the organs at risk seem to be limited within range 5. Operable (Standard or Limited surgery) or Inoperable 6. Age\>=20 7. No previous thoracic radiation 8. No previous chemotherapy 9. ECOG PS=0-2 10. Respiratory function (\<=14 days) PaO2\>=60 torr FEV1.0\>=700 ml 11. Written informed consent
Exclusion criteria
1. No apparent radiation pneumonitis and fibrosis 2. No active tuberculosis without oral drugs 3. No double cancer 4. No pregnancy 5. No psychiatric disorder 6. No steroid administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-years overall survival | During the study conduct |
Secondary
| Measure | Time frame |
|---|---|
| late complications | after 8 weeks from starting treatment day |
| serious complication rate | During the study conduct |
| Overall survival | During the study conduct |
| acute complications | within 8 weeks from starting treatment day |
| local-relapse free survival | During the study conduct |
| 3-years local relapse free survival | During the study conduct |
| patterns of relapse | During the study conduct |
| relapse-free survival | During the study conduct |
Countries
Japan
Outcome results
None listed