Chemoradiation versus Oesophagectomy for Locally Advanced Oesophageal Cancer in Chinese patients: study protocol for a randomized controlled trial
Abstract Background: Surgery is the gold standard treatment for local advanced disease, while definitive concurrent chemoradiotherapy (DCRT) is recommended for those who are medically unable to tolerate major surgery or medically fit patients who decline surgery. The primary aim of this trial is to compare the outcomes in Chinese oesophageal squamous cell cancer patients with locally advanced resectable disease who have received either surgery or DCRT. Methods/design: One hundred ninety-six patients with T1bN+M0 or T2-4aN0-2M0 oesophageal squamous cell cancer will be randomized to the DCRT group or the surgery group. In the DCRT group, patients will be given intensity modulation radiation therapy (IMRT) with 50 Gy/25 fractions and basic chemotherapy with 5-fluorouracil (5-FU) regimens. In the surgery group, patients will receive neoadjuvant chemoradiotherapy (NCRT) and standard oesophagectomy. Five years of follow-up will be scheduled for patients. The primary endpoints are 2-year/5-year overall survival; the secondary endpoints are 2-year/5-year progression-free survival, treatment-related adverse events and the patients’ quality of life. The main evaluation methods include oesophagoscopy, endoscopic ultrasonography and biopsy, oesophageal barium meal, CT, PET-CT, blood tests, and questionnaires. Discussion: The preponderant oesophageal cancer pathology type is dramatically different in western Caucasian and Asian oesophageal cancer patients: Caucasian patients present with 80% adenocarcinomas, and Asians patients present with 95% squamous cell carcinomas. This phenomenon needs more in-depth studies to elucidate the differences in these populations. Based on the results of this study, we will show whether DCRT will benefit patients more than oesophagectomy. It will contribute more evidence to the management of oesophageal squamous cell cancer. Trial registration: ClinicalTrials.gov identifier NCT02972372; registered on November 26, 2016;the URL of the trial registry record: https://clinicaltrials.gov/ct2/show/NCT02972372?term=shegan+gao&rank=1