NCT06012214

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress49%
Jan 2024Dec 2028

First Submitted

Initial submission to the registry

June 15, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

5 years

First QC Date

June 15, 2023

Last Update Submit

August 21, 2023

Conditions

Surgical Procedure, Unspecified

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • disease-free survival

    up to 5 year

  • oncologic results

    4 weeks

Study Arms (2)

Robot-assisted minimally invasive esophagectomy

EXPERIMENTAL

Participants will received neoadjuvant therapy followed by robot-assisted minimally invasive esophagectomy within 8 weeks.

Procedure: ROBOTIC-ASSISTED ESOPHAGECTOMY

Thoraco-laparoscopic minimally invasive esophagectomy

PLACEBO COMPARATOR

Participants will received neoadjuvant therapy followed by thoraco-laparoscopic minimally invasive esophagectomy within 8 weeks.

Procedure: ROBOTIC-ASSISTED ESOPHAGECTOMY

Interventions

ROBOTIC-ASSISTED ESOPHAGECTOMYPROCEDURE

Comparison between robotic and conventional minimally invasive esophagectomy

Robot-assisted minimally invasive esophagectomyThoraco-laparoscopic minimally invasive esophagectomy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest Hospital, Shanghai Jiao Tong University

Shanghai, SH 21, China

Location

Study Officials

  • Zhigang Li, Dr.

    Shanghai Chest Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Yang, Dr.

CONTACT

86 21-22200000*2116yangyang@shsmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

June 15, 2023

First Posted

August 25, 2023

Study Start

January 1, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

August 25, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)