BACKGROUND: Postoperative hemithoracic radiotherapy has been used to treat @entity3620 , but it has not been assessed in a randomised trial. We assessed high-dose hemithoracic radiotherapy after neoadjuvant chemotherapy and extrapleural pneumonectomy in @entity1 with @entity3620 . METHODS: We did this phase 2 trial in two parts at 14 hospitals in Switzerland, Belgium, and Germany. We enrolled @entity1 with pathologically confirmed @entity3620 ; resectable TNM stages T1-3 N0-2, M0; WHO performance status 0-1; age 18-70 years. In part 1, @entity1 were given three cycles of neoadjuvant chemotherapy ( @entity900 75 mg/m(2) and pemetrexed 500 mg/m(2) on day 1 given every 3 weeks) and extrapleural pneumonectomy; the primary endpoint was complete macroscopic resection (R0-1). In part 2, @entity1 with complete macroscopic resection were randomly assigned (1:1) to receive high-dose radiotherapy or not. The target volume for radiotherapy encompassed the entire hemithorax, the thoracotomy channel, and mediastinal nodal stations if affected by the disease or violated surgically. A boost was given to areas at high risk for locoregional relapse. The allocation was stratified by centre, histology (sarcomatoid vs epithelioid or mixed), mediastinal lymph node involvement (N0-1 vs N2), and T stage (T1-2 vs T3). The primary endpoint of part 1 was the proportion of @entity1 achieving complete macroscopic resection (R0 and R1). The primary endpoint in part 2 was locoregional relapse-free survival, analysed by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00334594. FINDINGS: We enrolled @entity1 between Dec 7, 2005, and Oct 17, 2012. Overall, we analysed 151 @entity1 receiving neoadjuvant chemotherapy, of whom 113 (75%) had extrapleural pneumonectomy. Median follow-up was 54  2 months (IQR 32-66). 52 (34%) of 151 @entity1 achieved an objective response. The most common grade 3 or 4 toxic effects were @entity1398 (21 [14%] of 151 @entity1 ), @entity417 (11 [7%]), and @entity390 or @entity391 (eight [5%]). 113 @entity1 had extrapleural pneumonectomy, with complete macroscopic resection achieved in 96 (64%) of 151 @entity1 . We enrolled 54 @entity1 in part 2; 27 in each group. The main reasons for exclusion were @entity1 refusal (n=20) and ineligibility (n=10). 25 of 27 @entity1 completed radiotherapy. Median total radiotherapy dose was 55  9 Gy (IQR 46  8-56  0). Median locoregional relapse-free survival from surgery, was 7  6 months (95% CI 4  5-10  7) in the no radiotherapy group and 9  4 months (6  5-11  9) in the radiotherapy group. The most common grade 3 or higher toxic effects related to radiotherapy were @entity390 or @entity391 (three [11%] of 27 @entity1 ), @entity354 (two [7%]), and @entity55 (two [7%]). One @entity1 died of @entity55 . We recorded no toxic effects data for the control group. INTERPRETATION: Our findings do not support the routine use of hemithoracic radiotherapy for @entity3620 after neoadjuvant chemotherapy and extrapleural pneumonectomy. FUNDING: Swiss Group for Clinical @entity5 Research, Swiss State Secretariat for Education, Research and Innovation, Eli Lilly.

Neoadjuvant chemotherapy and extrapleural pneumonectomy of XXXX with or without hemithoracic radiotherapy (SAKK 17/04): a randomised, international, multicentre phase 2 trial.

@entity1 :: ('9606', 'Species') :: ['participants', 'patients', 'patient'] @entity390 :: ('MESH:D009325', 'Disease') :: ['nausea'] @entity417 :: ('MESH:D000740', 'Disease') :: ['anaemia'] @entity55 :: ('MESH:D011014', 'Disease') :: ['pneumonitis'] @entity5 :: ('MESH:D009369', 'Disease') :: ['Cancer'] @entity900 :: ('MESH:D002945', 'Chemical') :: ['cisplatin'] @entity391 :: ('MESH:D014839', 'Disease') :: ['vomiting'] @entity3620 :: ('MESH:C562839', 'Disease') :: ['malignant pleural mesothelioma'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity354 :: ('MESH:D005764', 'Disease') :: ['oesophagitis']
@entity3620 :: (MESH:C562839,Disease) :: ['malignant pleural mesothelioma']
