BACKGROUND: The survival benefits of neoadjuvant chemotherapy (NAC) for esophagus squamous cell carcinoma (ESCC) remains controversial. The surgical procedure was not well defined in NAC strategy, in past trials. The different surgical procedure and different levels of lymphadenectomy may decrease the survival benefits from NAC. The new chemotherapy regimen with paclitaxel is promising. The purpose of this study is to confirm the superiority of paclitaxel, cisplatin and McKeown esophagectomy with total two-field lymphadenectomy compared with surgery alone for ESCC. METHODS: A two-arm phase III trial was launched in June 2015. A total of 528 patients will be recruited from eight Chinese institutions within 2.5 years. The overall survival (OS) is the primary endpoint, and the secondary endpoints include disease-free survival (DFS), R0 resection rate, complication rate, perioperation mortality, days of hospitalization, quality of life (QOL), NAC response rate, pathologic response rate, toxicities of NAC, prognostic factors, predictive factors, progression-free survival (PFS), and adverse events. DISCUSSION: The study will provide the final conclusion of NAC for ESCC in China. TRIAL REGISTRATION: NCT02442440 (https://register.clinicaltrials.gov/).
RCT Entities:
BACKGROUND: The survival benefits of neoadjuvant chemotherapy (NAC) for esophagus squamous cell carcinoma (ESCC) remains controversial. The surgical procedure was not well defined in NAC strategy, in past trials. The different surgical procedure and different levels of lymphadenectomy may decrease the survival benefits from NAC. The new chemotherapy regimen with paclitaxel is promising. The purpose of this study is to confirm the superiority of paclitaxel, cisplatin and McKeown esophagectomy with total two-field lymphadenectomy compared with surgery alone for ESCC. METHODS: A two-arm phase III trial was launched in June 2015. A total of 528 patients will be recruited from eight Chinese institutions within 2.5 years. The overall survival (OS) is the primary endpoint, and the secondary endpoints include disease-free survival (DFS), R0 resection rate, complication rate, perioperation mortality, days of hospitalization, quality of life (QOL), NAC response rate, pathologic response rate, toxicities of NAC, prognostic factors, predictive factors, progression-free survival (PFS), and adverse events. DISCUSSION: The study will provide the final conclusion of NAC for ESCC in China. TRIAL REGISTRATION: NCT02442440 (https://register.clinicaltrials.gov/).
Authors: Val Gebski; Bryan Burmeister; B Mark Smithers; Kerwyn Foo; John Zalcberg; John Simes Journal: Lancet Oncol Date: 2007-03 Impact factor: 41.316
Authors: David P Kelsen; Katryn A Winter; Leonard L Gunderson; Joanne Mortimer; Norman C Estes; Daniel G Haller; Jaffer A Ajani; Walter Kocha; Bruce D Minsky; Jack A Roth; Christopher G Willett Journal: J Clin Oncol Date: 2007-08-20 Impact factor: 44.544
Authors: M van Heijl; J J B van Lanschot; L B Koppert; M I van Berge Henegouwen; K Muller; E W Steyerberg; H van Dekken; B P L Wijnhoven; H W Tilanus; D J Richel; O R C Busch; J F Bartelsman; C C E Koning; G J Offerhaus; A van der Gaast Journal: BMC Surg Date: 2008-11-26 Impact factor: 2.102