Small-sized peripheral non-small cell lung cancer with clinical stage IA
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: All patients meet the following criteria(a-j). (a)Contrast-enhanced thoracic CT fulfills all of the following conditions (1)single tumor (2)non-small cell lung cancer (3)Center of tumor is located in the outer third of the peripheral lung field (4)no finding of metastasis of reginal lymph node (b)Thin-section CT fulfills either following conditions (1)maximum diameter of the tumor is 2cm or less (2)less than 3cm of the tumor size and less than 0.5 of consolidation tumor ratio (c)Age 20 to 79 years old (d)No prior ipsilateral thoracotomy (e)No prior chemotherapy or radiation therapy for any malignant diseases (f)Lobectomy tolerable (g)0 or 1 of performance status (h)Sufficient organ functions (i)38centigrade or less of preoperative body temperature (j)Written informed consent obtained
Exclusion criteria
Exclusion criteria: All patients must NOT meet the following criteria. a)Active bacterial or fungous infection b)Simultaneous or metachronous (within the past 5 years) double cancers c)Women during pregnancy or breast-feeding d)Interstitial pneumonia, lung fibrasis or severe emphysema e)Psychosis or psychiatric condition unsuitable for carbon-ion ratiotherapy or surgery f)Systemic steroids medication g)Intractable diabetes mellitus. h)Intractable hypertension i)History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months j)Metal devices in the lesion k)Other medical or psychological condition which is unsuitable for carbon-ion radio therapy or surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Five-year overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Relapse-free survival, Cause-specific survival b) Local recurrence c) Adverse reaction d) Respiratory function post-surgery or carbon-ion therapy e) Length of hospital stay | — |
Countries
Japan
Contacts
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization Ion-beam Radiation Oncology Center