Spots Global Cancer Trial Database for Robot-assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy
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Trial Identification
Brief Title: Robot-assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy
Official Title: Robot-assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy for Patients With Squamous Cell Esophageal Cancer: a Multicenter Open-label, Randomized Controlled Trial (RAMIE Trial)
Study ID: NCT03094351
Study Description
Brief Summary: This is the first randomized controlled study to compare the robot-assisted esophagectomy (RAE) to minimally invasive conventional thoracoscopic esophagectomy (CTE). The aim of this trial is to evaluate the safety, risks of the robot-assisted esophagectomy, and to compare the short-term operative outcomes and long-term oncological outcomes between the two surgical treatments.
Detailed Description: Objective: This study aims to compare the oncological outcomes between robot-assisted esophagectomy and minimally invasive conventional thoracoscopic esophagectomy. Study design: Randomized controlled parallel-group superiority trial Study population: Patients (age \>= 18 and \<= 75 years) with histologically proven surgically resectable (cT1b-3, N0-2, M0) squamous cell carcinoma of the intrathoracic esophagus with European Clinical Oncology Group performance status 0, 1 or 2. Intervention: 360 patients will be randomly allocated to either A) robot-assisted esophagectomy (n=180) or B) conventional thoracoscopic esophagectomy (n=180). Patients will receive the following interventions: Group A. robot assisted esophagectomy, with gastric conduit formation. Group B. conventional thoracoscopic esophagectomy, with gastric conduit formation. Main study parameters/endpoints: Primary outcome is 5-year overall survival rate. Secondary outcomes are 5-year disease free survival, 3-year overall survival rate, 3-year disease free survival, (in hospital) mortality within 30 and 60 days, R0 resections, operation related events, postoperative recovery, lymph nodes status, quality of life. Follow-up: 60 months after discharge of the last randomized patient.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
General hospital of eastern theater command, Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Changhai Hospital, The Second Military Medical University, Shanghai, , China
Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, , China
Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, , China
Zhongshan Hospital, Fudan University, Shanghai, , China
Contact Details
Name: Zhigang Li, Master
Affiliation: Shanghai Chest Hospital, Shanghai Jiao Tong University
Role: PRINCIPAL_INVESTIGATOR
Name: Hecheng Li, Master
Affiliation: Ruijin Hospital
Role: STUDY_DIRECTOR
Name: Hezhong Chen, Master
Affiliation: Changhai Hospital, the Second Military Medical University
Role: STUDY_DIRECTOR
Name: Lijie Tan, Master
Affiliation: Fudan University
Role: STUDY_DIRECTOR
Name: Bentong Yu, Master
Affiliation: The First of Affiliated Hospital of Nanchang University
Role: STUDY_DIRECTOR
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