PURPOSE: To evaluate, in Japan Clinical Oncology Group study 0403, the safety and efficacy of stereotactic body radiation therapy (SBRT) in @entity1 with T1N0M0 @entity1149 ( @entity1149 ). METHODS AND MATERIALS: Eligibility criteria included histologically or cytologically proven @entity1149 , clinical T1N0M0. Prescribed dose was 48  Gy at the isocenter in 4 fractions. The primary endpoint was the percent (%) 3-year overall survival. The threshold % 3-year survival to be rejected was set at 35% for inoperable @entity1 , whereas the expected % 3-year survival was 80% for operable @entity1 . RESULTS: Between July 2004 and November 2008, 169 @entity1 from 15 institutions were registered. One hundred inoperable and 64 operable @entity1 (total 164) were eligible. @entity1 ' characteristics were 122 male, 47 female; median age 78  years (range, 50-91  years); @entity420 , 90; @entity957 , 61; others, 18. Of the 100 inoperable @entity1 , the % 3-year OS was 59.9% (95% confidence interval 49.6%-68.8%). Grade 3 and 4 @entity137 were observed in 10 and 2 @entity1 , respectively. No grade 5 @entity137 was observed. Of the 64 operable @entity1 , the % 3-year OS was 76.5% (95% confidence interval 64.0%-85.1%). Grade 3 @entity137 were observed in 5 @entity1 . No grade 4 and 5 @entity137 were observed. CONCLUSIONS: Stereotactic body radiation therapy for stage I @entity1149 is effective, with low incidences of severe @entity137 . This treatment can be considered a standard treatment for inoperable stage I @entity1149 . This treatment is promising as an alternative to surgery for operable stage I @entity1149 .

Prospective Trial of Stereotactic Body Radiation Therapy for Both Operable and Inoperable T1N0M0 XXXX : Japan Clinical Oncology Group Study JCOG0403.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'toxicities'] @entity957 :: ('MESH:D002294', 'Disease') :: ['squamous cell carcinomas'] @entity1149 :: ('MESH:D002289', 'Disease') :: ['NSCLC', 'non-small cell lung cancer'] @entity420 :: ('MESH:D000230', 'Disease') :: ['adenocarcinomas']
@entity1149 :: (MESH:D002289,Disease) :: ['Non-Small Cell Lung Cancer']
