Primary lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Pathologically proven non-small cell lung cancer 2) T1-3N0M0(UICC 7th edition) 3) Inoperative or operation refused 4) Visible target on CT 5) ECOG-PS 0-2 6) Age 20-yrs old or over at the time of consent form is obtained 7) Explained well and consent to this study
Exclusion criteria
Exclusion criteria: 1) With active infections in the irradiated sites 2) With active other cancers 3) With severe uncontrolled diabetes 4) With severe renal failure which needed dialysis 5) With severe heart disease, or some serious complications, i.e., SLE, Scleroderma, interstitial pneumonia 6) Previous thoracic irradiation 7) Previous chemotherapy within 12 months before enrollment 8) FEV 1.0 under 700 ml 9) With implantable cardioverter defibrillator or permanent pacemaker 10) Pregnancy 11) Considered that participation in this trial is difficult because of psychiatric symptoms or psychosis 12) Cannot be held rest for about 30 minutes 13) Weight over 135 kg 14) Cannot be implanted Au marker in the lung 15) Allergic to radiation 16) Unsuitable for enrollment judged by principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of radiation pneumonitis at six months after real-time tumor-tracking proton beam therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year overall survival, local control, progression free survival, recurrence pattern, incidence of adverse effect, incidence of dropout and migration of Au markers during treatment period | — |
Countries
Japan
Contacts
Hokkaido University Graduate School of Medicine Department of Radiation Medicine