BACKGROUND: One of the standard options in the treatment of stage IIIA/N2 @entity1149 is neoadjuvant chemotherapy and surgery. We did a randomised trial to investigate whether the addition of neoadjuvant radiotherapy improves outcomes. METHODS: We enrolled @entity1 in 23 centres in Switzerland, Germany and Serbia. Eligible @entity1 had pathologically proven, stage IIIA/N2 @entity1149 and were randomly assigned to treatment groups in a 1:1 ratio. Those in the chemoradiotherapy group received three cycles of neoadjuvant chemotherapy (100 mg/m(2) @entity900 and 85 mg/m(2) @entity1205 ) followed by radiotherapy with 44 Gy in 22 fractions over 3 weeks, and those in the control group received neoadjuvant chemotherapy alone. All @entity1 were scheduled to undergo surgery. Randomisation was stratified by centre, mediastinal bulk (less than 5 cm vs 5 cm or more), and @entity353 (5% or more vs less than 5% in the previous 6 months). The primary endpoint was event-free survival. Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00030771. FINDINGS: From 2001 to 2012, 232 @entity1 were enrolled, of whom 117 were allocated to the chemoradiotherapy group and 115 to the chemotherapy group. Median event-free survival was similar in the two groups at 12  8 months (95% CI 9  7-22  9) in the chemoradiotherapy group and 11  6 months (8  4-15  2) in the chemotherapy group (p=0  67). Median overall survival was 37  1 months (95% CI 22  6-50  0) with radiotherapy, compared with 26  2 months (19  9-52  1) in the control group. Chemotherapy-related toxic effects were reported in most @entity1 , but 91% of @entity1 completed three cycles of chemotherapy. Radiotherapy-induced grade 3 @entity1282 was seen in seven (7%) @entity1 . Three @entity1 died in the control group within 30 days after surgery. INTERPRETATION: Radiotherapy did not add any benefit to induction chemotherapy followed by surgery. We suggest that one definitive local treatment modality combined with neoadjuvant chemotherapy is adequate to treat resectable stage IIIA/N2 @entity1149 . FUNDING: Swiss State Secretariat for Education, Research and Innovation (SERI), Swiss Cancer League, and Sanofi.

Induction chemoradiation in stage IIIA/N2 XXXX : a phase 3 randomised trial.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity353 :: ('MESH:D015431', 'Disease') :: ['weight loss'] @entity1149 :: ('MESH:D002289', 'Disease') :: ['non-small-cell lung cancer'] @entity900 :: ('MESH:D002945', 'Chemical') :: ['cisplatin'] @entity1282 :: ('MESH:D003680', 'Disease') :: ['dysphagia'] @entity1205 :: ('MESH:C067311', 'Chemical') :: ['docetaxel']
@entity1149 :: (MESH:D002289,Disease) :: ['non-small-cell lung cancer']
