AzTrials
AzTrials

Esophageal CancerPhase 3RAE vs CTENCT03094351

Robot-assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy

A Phase 3 study testing esophagectomy in people with Esophageal Cancer and Esophageal Carcinoma, run by Shanghai Chest Hospital at 6 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Cancer, Esophageal Carcinoma
What is being tested?
esophagectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
6 sitesChina
Study dates
29 Jul 2017to 1 Dec 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven squamous cell carcinoma of the intrathoracic esophagus.
  • Surgical resectable (T1b-3, N0-2, M0)
  • Age ≥ 18 and ≤ 75 years
  • European Clinical Oncology Group performance status 0, 1 or 2
  • Written informed consent

Who cannot join

  • Carcinoma of the cervical esophagus
  • Histologically proven adenocarcinoma or undifferentiated carcinoma.
  • Prior thoracic surgery at the right hemithorax or thorax trauma.
  • Infectious disease with systemic therapy indicated.

Trial locations and contacts

6 sites in 1 country.

Zhigang Li, Master contact

86-18930619260

zhigang.li@shchest.org

Xiaobin Zhang, Doctor contact

86-18516302162

zxb5212@163.com

6 sites in 1 country

China6 sites, 6 recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, JX 791

    Bentong Yu, Doctor, 86-13870614026, yubentong@126.com

    Recruiting

  • General hospital of eastern theater command

    Nanjing, Jiangsu, JS 25

    Jun Yi, Doctor, 8613675101301, njyijun@163.com

    Recruiting

  • Changhai Hospital, The Second Military Medical University

    Shanghai, SH 21

    Hezhong Chen, Doctor, 86-13301783183, drchenhz@citiz.net

    Recruiting

  • Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine

    Shanghai, SH 21

    Hecheng Li, Doctor, 86-13917113402, lihecheng2000@hotmail.com

    Recruiting

  • Shanghai Chest Hospital, Shanghai Jiao Tong University

    Shanghai, SH 21

    Zhigang Li, Doctor, 86-18930619260, zhigang.li@shchest.org

    Recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai, SH 21

    Lijie Tan, Doctor, 86-13681972151, tan.lijie@zs-hospital.sh.cn

    Recruiting

Other trials in China

About this study

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)

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.

Read the 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.

Being tested
esophagectomy
Keywords
robot assisted esophagectomy, minimally invasive esophagectomy, esophageal cancer
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • esophagectomyProcedure or surgery

    Also called minimally invasive esophagectomy

    Robot assisted esophagectomy with extended two field lymphadenectomy.

  • esophagectomyProcedure or surgery

    Also called minimally invasive esophagectomy

    Conventional thoracoscopic esophagectomy with extended two field lymphadenectomy.

Study groups in NCT03094351
Study groupRoleWhat they receive
Robot assisted esophagectomyExperimentalRobot-assisted esophagectomy with gastric conduit formation.
Receives: Procedure: esophagectomy
Thoracoscopic esophagectomyActive comparatorConventional thoracoscopic esophagectomy with gastric conduit formation.
Receives: Procedure: esophagectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival Rate

    Measured: 5 years

Secondary outcomes (11)

  1. R0 resection (%)

    Measured: within 30 days after surgery

  2. Overall Survival Rate

    Measured: 3 years

  3. Disease Free Survival Rate

    Measured: 3 years

  4. Postoperative major complications

    Measured: 30 days after surgery

  5. In hospital mortality

    For all patients, the cause of death will be noted. If applicable, the results of the autopsy report will be noted.

    Measured: 30-60 days after surgery

  6. Operative duration

    The operation time is defined as time from incision until closure (minutes) for both the thoracic phase and the abdominal phase of the procedure. For the robotic procedure, the set-up time will be recorded separately.

    Measured: during the operation, up to 5 hours

  7. Postoperative recovery

    Postoperative hospital stay, intensive care unit (ICU) stay

    Measured: from the date of surgery to the hospital discharge, assessed up to 15 days

  8. Number of lymph nodes dissected

    Measured: within 30 days after surgery

  9. Quality of life

    The quality of life assessment was based on a previously validated questionnaire, QLQ-C30 (version 3.0; quality-of-life questionnaire), combined with an esophageal cancer-specific module, QLQ-OES18.

    Measured: 2 years

  10. Estimated blood loss

    Measured: during the operation, up to 5 hours

  11. Disease Free Survival Rate

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2017
  2. Study start29 Jul 2017
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
None (open label)
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03094351
Sponsor's protocol ID
RAE20170320
Acronym
RAE vs CTE
Status last verified
Feb 2019
First submitted
20 Mar 2017
Last updated
5 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yang Y, Liu Z, Li C, Li B, Yu B, Yi J, Zhang X, Chen H, Li H, Tan L, Hua R, Guo X, Yang X, Ma W, Sun Y, Li Z; RAMIE study group. Robot-assisted versus conventional minimally invasive oesophagectomy for oesophageal squamous cell carcinoma (RAMIE): a multicentre, open-label, randomised, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2026 Jun;11(6):452-462. doi: 10.1016/S2468-1253(25)00402-9. Epub 2026 Mar 31.

    PubMed 41932350

  • Yang Y, Li B, Yi J, Hua R, Chen H, Tan L, Li H, He Y, Guo X, Sun Y, Yu B, Li Z. Robot-assisted Versus Conventional Minimally Invasive Esophagectomy for Resectable Esophageal Squamous Cell Carcinoma: Early Results of a Multicenter Randomized Controlled Trial: the RAMIE Trial. Ann Surg. 2022 Apr 1;275(4):646-653. doi: 10.1097/SLA.0000000000005023.

    PubMed 34171870

  • Yang Y, Zhang X, Li B, Li Z, Sun Y, Mao T, Hua R, Yang Y, Guo X, He Y, Li H, Chen H, Tan L. Robot-assisted esophagectomy (RAE) versus conventional minimally invasive esophagectomy (MIE) for resectable esophageal squamous cell carcinoma: protocol for a multicenter prospective randomized controlled trial (RAMIE trial, robot-assisted minimally invasive Esophagectomy). BMC Cancer. 2019 Jun 21;19(1):608. doi: 10.1186/s12885-019-5799-6.

    PubMed 31226960

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing esophagectomy in people with Esophageal Cancer and Esophageal Carcinoma, run by Shanghai Chest Hospital at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhigang Li, Master (86-18930619260, zhigang.li@shchest.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival Rate (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03094351, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in