Research

Radiotherapy quality assurance review in a multi-center randomized trial of limited-disease small cell lung cancer: the Japan Clinical Oncology Group (JCOG) trial 0202

Naoko Sanuki-Fujimoto^1* , Satoshi Ishikura^1,2* , Kazushige Hayakawa² , Kaoru Kubota³ , Yutaka Nishiwaki³ and Tomohide Tamura³

¹  Clinical Trials and Practice Support Division, Center for Cancer Control and Information Services, National Cancer Center, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan

²  JCOG radiotherapy committee, Clinical Trials and Practice Support Division, Center for Cancer Control and Information Services, National Cancer Center 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan

³  JCOG lung cancer study group, Thoracic Oncology Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan

author email corresponding author email* Contributed equally

Radiation Oncology 2009, 4:16doi:10.1186/1748-717X-4-16

Published:	2 June 2009

Abstract

Background

The purpose of this study was to analyze the radiotherapy (RT) quality assurance (QA) assessment in Japan Clinical Oncology Group (JCOG) 0202, which was the first trial that required on-going RT QA review in the JCOG.

Methods

JCOG 0202 was a multi-center phase III trial comparing two types of consolidation chemotherapy after concurrent chemoradiotherapy for limited-disease small cell lung cancer. RT requirements included a total dose of 45 Gy/30 fx (bis in die, BID/twice a day) without heterogeneity correction; elective nodal irradiation (ENI) of 30 Gy; at least 1 cm margin around the clinical target volume (CTV); and interfraction interval of 6 hours or longer. Dose constraints were defined in regards to the spinal cord and the lung. The QA assessment was classed as per protocol (PP), deviation acceptable (DA), violation unacceptable (VU), and incomplete/not evaluable (I/NE).

Results

A total of 283 cases were accrued, of which 204 were fully evaluable, excluding 79 I/NE cases. There were 18 VU in gross tumor volume (GTV) coverage (8% of 238 evaluated); 4 VU and 23 DA in elective nodal irradiation (ENI) (2% and 9% of 243 evaluated, respectively). Some VU were observed in organs at risk (1 VU in the lung and 5 VU in the spinal cord). Overall RT compliance (PP + DA) was 92% (187 of 204 fully evaluable). Comparison between the former and latter halves of the accrued cases revealed that the number of VU and DA had decreased.

Conclusion

The results of the RT QA assessment in JCOG 0202 seemed to be acceptable, providing reliable results.