The ROMIO trial - Randomised Oesophagectomy: Minimally Invasive or Open, a feasibility study

niversity of Bristol (UK)0 个研究点目标入组 273 人开始时间: 2013年2月25日最近更新: 2024年6月18日

适应症

试验速览

2014 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/24888266 protocol 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27373720 results 2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/30826769 quality assurance protocol (added 30/03/2020)

•1. Male or female patients
•2. Over 18 years of age
•3. Oesophageal or oesophagogastric junctional adenocarcinoma, squamous cell cancer or high grade dysplasia
•4. Endoscopic evidence before treatment of a tumour starting more than 5cm below cricopharyngeus
•5. Endoscopic evidence before treatment of a tumour involving less than 4 centimetres of the gastric wall
•6. Final tumour stage between high grade dysplasia and T3N1M0
•7. Referred for primary oesophagectomy or referred for oesophagectomy after neoadjuvant treatment
•8. Able to provide written informed consent

•1. Stage 4 disease
•2. Type 3 tumours of the oesophagogastric junction
•3. Localised squamous cell cancer who elect to undergo definitive chemoradiotherapy
•4. High grade dysplasia who elect to undergo radiofrequency ablation or endoscopic mucosal resection
•5. Evidence of previous complex thoracotomies or laparotomies
•6. Evidence of previous/concomitant malignancy that would interfere with the study protocol
•7. Pregnancy
•8. Participating randomised trials that may interfere with this protocol

发起方

niversity of Bristol (UK)