RAE Versus MIE in Patients With Esophageal Cancer After Neoadjuvant Therapy

Robot-assisted Versus Conventional Minimally Invasive Esophagectomy for Locally Advanced Esophageal Squamous Cell Carcinoma After Neoadjuvant Therapy: a Prospective Randomized Controlled Trial

This is a prospectively randomized controlled trial to compare RAMIE and MIE in the treatment for locally advanced ESCC after neoadjuvant therapy. According to previous studies, long-term survival after RAMIE seemed to be at least comparable to MIE or open esophagectomy. Therefore, the RAMIE-2 study was designed as a non-inferiority trial, which was based on the hypothesis that the 5-year overall survival of patients who received RAMIE is uncompromised to MIE. To achieve the primary endpoint, 260 cases will be recruited in our hospital. Based on the volume of esophagectomy (1000 cases/year) and the proportion of patients with neoadjuvant therapy (50%) in our institution, approximately 10 patients will be enrolled for each group per month for this trial. The study will be performed in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice Guidelines. Written informed consent will be obtained from each participant. The flow chart of this trial is also presented.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgical Procedure, Unspecified
• Intervention / Treatment: Procedure: ROBOTIC-ASSISTED ESOPHAGECTOMY

Detailed Description

Neoadjuvant therapy followed by radical resection is the recommended treatment for locally advanced esophageal cancer, which could achieve a better R0 resection and overall survival. With the development of multidisciplinary treatment of esophageal cancer, especially the emerging concept of "watch and wait", surgery may only be a new era of salvage treatment for patients with poor response to neoadjuvant or recurrence after definitive treatment in the future. At that time, the technical advantage of RAMIE should be even more valuable. Early results of the RAMIE trial (conducted by our group)15, has demonstrated that RAMIE can achieve shorter operative time as well as better lymph node dissection in patients who received neoadjuvant therapy, compared to conventional MIE. In addition, this benefit was more obviously observed in lymph nodes along the bilateral recurrent laryngeal nerves, which were considered as the most challenging steps.

Therefore, we put forward a hypothesis: whether the robot's superior human-surgical interface is beneficial to achieve better surgical and oncological results in patients with locally advanced ESCC after neoadjuvant therapy. Based on the results of RAMIE trial, the present RAMIE-2 study is trying to answer such a question.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yang Yang, Dr.; Phone Number: 86 21-22200000*2116; Email: yangyang@shsmu.edu.cn

Study Locations

• China
  • Shanghai, China, SH 21
    • Shanghai Chest Hospital, Shanghai Jiao Tong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ranges from 18 to 75 years;
2. European Clinical Oncology Group Performance Status (ECOG PS) 0-2;
3. Histological subtype of esophageal squamous cell carcinoma;
4. Primary tumors are located at the intrathoracic esophagus;
5. Pre-treatment stage as cT1b-4aN1-3M0, cT3N0M0 (AJCC/UICC 8th Edition);
6. With neoadjuvant chemoradiotherapy, chemotherapy and immunotherapy;
7. Without any anticancer therapy for other malignant diseases;
8. Written informed consent.

Exclusion Criteria:

1. Cervical esophageal cancer and carcinoma of gastro-esophageal junction;
2. Patients with unresectable or metastatic esophageal cancer;
3. Histological subtype of esophageal non-squamous cell carcinoma;
4. History of previous thoracic surgery;
5. Patients with other malignant tumor (previous or current);
6. Participation in another clinical trial during this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot-assisted minimally invasive esophagectomy; Participants will received neoadjuvant therapy followed by robot-assisted minimally invasive esophagectomy within 8 weeks.	Procedure: ROBOTIC-ASSISTED ESOPHAGECTOMY; Comparison between robotic and conventional minimally invasive esophagectomy
Placebo Comparator: Thoraco-laparoscopic minimally invasive esophagectomy; Participants will received neoadjuvant therapy followed by thoraco-laparoscopic minimally invasive esophagectomy within 8 weeks.	Procedure: ROBOTIC-ASSISTED ESOPHAGECTOMY; Comparison between robotic and conventional minimally invasive esophagectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	defined as the time from the date of surgery to the day of death or to the last follow-up.	up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease-free survival	defined as the time from the date of surgery to the day of tumor recurrence, tumor progression or death assessed up to 5 years	up to 5 year
oncologic results	number of lymph nodes dissection, R0 resection rate	4 weeks

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital
• Investigators: Principal Investigator: Zhigang Li, Dr., Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RAMIE-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No