A Phase II Study of Stereotactic Body Radiation Therapy in Patients With T1N0M0 Non-small Cell Lung Cancer (JCOG0403)

Study Overview
=================
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.

Official Title
-----------------
A Phase II Study of Stereotactic Body Radiation Therapy in Patients With T1N0M0 Non-small Cell Lung Cancer (JCOG0403)

Conditions
-----------------
T1N0M0 Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Procedure: stereotactic body radiation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or transbronchoscopic cytologically confirmed non-small cell lung cancer Stage IA with images within 28 days No other intrathoracic lesions Dose constraints of the organs at risk seem to be limited within range Operable (Standard or Limited surgery) or Inoperable Age>=20 No previous thoracic radiation No previous chemotherapy ECOG PS=0-2 Respiratory function (<=14 days) PaO2>=60 torr FEV1.0>=700 ml Written informed consent Exclusion Criteria: No apparent radiation pneumonitis and fibrosis No active tuberculosis without oral drugs No double cancer No pregnancy No psychiatric disorder No steroid administration

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Procedure/Surgery: stereotactic body radiation therapy | Procedure: stereotactic body radiation therapy<br>* Procedure/Surgery: stereotactic body radiation therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-years overall survival |  | During the study conduct | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | During the study conduct | 
| relapse-free survival |  | During the study conduct | 
| 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 | 
| acute complications |  | within 8 weeks from starting treatment day | 
| late complications |  | after 8 weeks from starting treatment day | 
| serious complication rate |  | During the study conduct | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stereotactic body radiation therapy, T1N0M0 non-small cell lung cancer, radiotherapy