Feasibility of omitting the clinical target volume under PET-CT guidance in unresectable stage III non-small-cell lung cancer: A phase II clinical trial.

BACKGROUND:This clinical trial aims at investigate the feasibility of CTV-omitted, positron-emission tomography computed tomography (PET-CT) combined with intensity-modulated radiation therapy (IMRT) for unresectable stage III NSCLC. METHODS AND MATERIALS:This was a single-center, phase II clinical trial initiated in July 2016. Patients with unresectable stage III NSCLC undergoing routine IMRT were randomly enrolled into the study group (CTV-omitted under PET-CT guidance) and the control group (CTV-delineated). Patients received platinum-based dual-drug concurrent chemoradio therapy. In the study group, the PGTV dose was 60 Gy given in 30 daily 2 Gy fractions; in the control group, the PCTV dose was 54 Gy given in 30 daily 1.8 Gy fractions, and the PGTV dose was 60 Gy given in 30 daily 2 Gy fractions. The primary endpoint was the incidence of radiation respiratory events or esophagitis with grade 3 or higher. The secondary endpoints included objective response rate (ORR), locate control rate, progression-free survival (PFS), failure pattern and overall survival (OS). RESULTS:A total of 90 patients were enrolled between July 2016 and March 2019. The incidence of radiation respiratory events or esophagitis with grade 3 or higher was 11.1 % in the study group, significantly lower than the rate of 28.9 % in the control group (P = 0.035), basically due to the reduced irradiated volumes of the lungs and esophagus in the study group. The median PFS was 9.0 months versus 10.0 months (P = 0.597), and the median OS 31.0 months versus 26.0 months (P = 0.489) in the study group and the control group, respectively. The failure pattern was not significantly different between the two groups (P = 0.826). CONCLUSION:Omitting the CTV under PET-CT guidance has high feasibility to reduce severe radiation associated toxicity in IMRT for unresectable stage III NSCLC, without compromising the efficacy.