Peripherally located inoperable stage-I non-small-cell lung cancer
Conditions
Interventions
Carbon-ion radiotherapy 60.0GyRBE/4fractions (15.0GyRBE/fraction)
Sponsors
Ion Beam Therapy Center, SAGA-HIMAT Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Pathologically confirmed or clinically diagnosed NSCLC 2)Clinically T1-T2aN0M0 diagnosed by imaging examinations including FDG-PET, and peripherally located 3)Considered to be unfit to lobar resection by cancer board including thoracic surgeon, pulmonary medical oncologist and radiation oncologist 4)Exist of lesion for evaluation 5)Initial treatment for the lesion 6)PS(ECOG) 0-2 7)SpO2 >= 90% or PaO2 >= 60 torr(mmHg) 8)FEV1.0 >= 700ml 9)>= 20 years-old / =< 90 years-old 10)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Severe comorbidities including infection and mental disorders 2) Interstitial pneumonitis on CT images 3)Coexisting malignancies within 2 years excepting Carcinoma in situ, stage-I laryngeal cancer, stage-I prostate cancer and stage-I breast cancer 4)History of thoracic irradiation 5)Pregnancy 6)Enrolled in other clinical trials with Interventions 7)Other reasons judged by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year overall survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicities Median survival time 2-year overall survival rate 2- and 3-year cause-specific survival rate 2- and 3-year progression-free survival rate 2- and 3-year local-progression-free rate 2- and 3-year local-progression-free survival rate Pattern of recurrences | — |
Countries
Japan
Contacts
Public Contacthiroaki suefuji
Ion Beam Therapy Center, SAGA-HIMAT Foundation Department of Radiation Oncology
Outcome results
None listed