Peripherally located stage-I non small cell lung cancer
Conditions
Interventions
Carbon-ion radiotherapy 1) Based on a total dose of 60.0 Gy(RBE), 54.0 to 64.0 Gy(RBE) / 4 fractions 2) A total dose of 50.0 Gy(RBE) / 1 fraction 3) A total dose of 64.0 to 72.0 Gy(RBE) / 12 to 16
Sponsors
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically confirmed or clinically diagnosed NSCLC 2) Clinically IA-IB diagnosed by imaging examnations including FDG-PET, and peripherally located (2017, UICC 8th) 3) Patients who are judged to be unable to resect lobectomy* by examination with a cancer board including doctors of thoracic surgeon, respiratory medicine and radiation oncologst it is judged that patients can be operated or surgery is possible, but patients who hope carbon-ion radiotherapy *The case of not satisfying even one of this conditions (a) to (f) below shall be defined as inoperable in this study. (a) Postopenative prognosis FEV1.0 > 800ml (b) PaO2 > 65mmHg or SaO2 > 92% (C) 0 to 1 of performance status (ECOG) (d) There is enough cardiac activity, the patients who are judged as operable (e) There is not diabetes that it is hard to control with insulin (f) No severe complications, the patients who are judged as operable 4) Exist of lesion for evaluation 5) Initial treatment for the lesion 6) 0 to 2 of performance status (ECOG) 7) Aged 20 or above at the time of registration 8) Patient who is ineligible for other clinical trials including Advanced Medicine Program B (Sen-shin Iryo B) 9) Written concent obtained for the participation in this study
Exclusion criteria
Exclusion criteria: 1) Severe comorbidities including infection and mental disorders 2) Interstitial pneumonitis on CT images 3) Patient with active double cancer, active and untreated double cancer, except for intraepithelial carcinoma, intramucinous carcinoma or malignancy controlled for a long-term 4) Interstitial pneumonitis on CT images 5) Pregnant women, women who may become pregnant 6) When it is not possible to confirm the intention of the person by the decline of cognitive function 7) Medically or psychologically unsuitable conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who developed glade 2 or early severe adverce events related to lung and skin | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Local progression free survival 2) Overall survival 3) Adverse event rate 4) Progression free survival 5) Pattern of recurrences | — |
Countries
Japan
Contacts
Public ContactDr. Daisaku Yoshida
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization Ion-beam Radiation Oncology Center
Outcome results
None listed