BACKGROUND: This study compared prophylactic cranial irradiation (PCI) with observation in @entity1 with resected stage IIIA-N2 @entity1149 ( @entity1149 ) and high risk of cerebral metastases after adjuvant chemotherapy. @entity1 AND METHODS: In this open-label, randomized, phase III trial, @entity1 with fully resected postoperative pathologically confirmed stage IIIA-N2 @entity1149 and high cerebral metastases risk without recurrence after postoperative adjuvant chemotherapy were randomly assigned to receive PCI (30 Gy in 10 fractions) or observation. The primary end point was @entity66 ( @entity66 ). The secondary end points included the incidence of brain metastases, overall survival (OS), @entity137 and quality of life. RESULTS: This trial was terminated early after the random assignment of 156 @entity1 (81 to PCI group and 75 to control group). The PCI group had significantly lengthened @entity66 compared with the control group, with a median @entity66 of 28.5 months versus 21.2 months [hazard ratio (HR), 0.67; 95% confidence interval (CI) 0.46-0.98; P = 0.037]. PCI was associated with a decrease in risk of brain metastases (the actuarial 5-year brain metastases rate, 20.3% versus 49.9%; HR, 0.28; 95% CI 0.14-0.57; P < 0.001). The median OS was 31.2 months in the PCI group and 27.4 months in the control group (HR, 0.81; 95% CI 0.56-1.16; P = 0.310). While main @entity137 were @entity10 , @entity390 / @entity391 and fatigue in the PCI group, they were generally mild. CONCLUSION: In @entity1 with fully resected postoperative pathologically confirmed stage IIIA-N2 @entity1149 and high risk of cerebral metastases after adjuvant chemotherapy, PCI prolongs @entity66 and decreases the incidence of brain metastases.

Randomized phase III trial of prophylactic cranial irradiation versus observation in XXXX with fully resected stage IIIA-N2 @entity1149 and high risk of cerebral metastases after adjuvant chemotherapy

@entity1 :: ('9606', 'Species') :: ['patients', 'PATIENTS'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'toxicities'] @entity390 :: ('MESH:D009325', 'Disease') :: ['nausea'] @entity66 :: ('MESH:D004194', 'Disease') :: ['DFS', 'disease-free survival'] @entity1149 :: ('MESH:D002289', 'Disease') :: ['NSCLC', 'non-small-cell lung cancer'] @entity391 :: ('MESH:D014839', 'Disease') :: ['vomiting'] @entity10 :: ('MESH:D006261', 'Disease') :: ['headache']
@entity1 :: (9606,Species) :: ['patients']
