RAMIE Versus MIE for Resectable Esophageal Cancer, a Randomized Controlled Trial (ROBOT-2 Trial).

NCT04306458 | Recruiting DMC

• 1 other identifier: ROBOT2 trial
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND: For patients with esophageal cancer, radical esophagectomy with 2-field lymphadenectomy is the cornerstone of the multimodality treatment with curative intent. Both, conventional minimally invasive esophagectomy (MIE) and robot assisted minimally invasive esophagectomy (RAMIE) were shown to be superior compared to open transthoracic esophagectomy considering postoperative complications. However, no randomized comparison was made until now to compare MIE to RAMIE OBJECTIVES: The objective is to evaluate the extent of lymph node dissection, efficacy, risks, quality of life and cost-effectiveness of RAMIE as an alternative to MIE as treatment for esophageal adenocarcinoma or adenocarcinoma of the gastroesophageal junction.. METHODS: This is an investigator-initiated and investigator-driven multicenter randomized controlled parallel-group, superiority trial. All adult patients (age ≥18 and ≤ 90 years) with histologically proven, surgically resectable (cT1-4a, N0-3, M0) adenocarcinoma of the intrathoracic esophagus or adenocarcinoma of the gastroesophageal junction with European Clinical Oncology Group performance status 0, 1 or 2 will be assessed for eligibility and included after obtaining informed consent. Patients (n=218) are randomized at the outpatient department to either RAMIE (n=109) or MIE (n=109). The primary outcome of this study is the total number of resected lymph nodes according to the TIGER classification for esophageal cancer lymphadenectomy. CONCLUSION: This is the first randomized controlled trial designed to compare RAMIE to MIE as surgical treatment for resectable adenocarcinoma of the intrathoracic esophagus or adenocarcinoma of the gastroesophageal junction in the Western World. If our hypothesis is proven correct, RAMIE will result in a better lymph node dissection compared to conventional MIE. The study started in September 2019. Follow up will be 5 years. Short term results will be analyzed and published after discharge of the last randomized patient.

Conditions

Esophageal Adenocarcinoma

Keywords

minimally invasive esophagectomy; robot assisted minimally invasive esophagectomy; MIE; RAMIE; lymph node dissection; lymphadenectomy

Outcome Measures

Primary Outcomes (1)

• Total number of dissected lymph nodes

  Total number of dissected lymph nodes in the resection specimen according to the TIGER classification

  Up to 2 weeks postoperatively

Secondary Outcomes (14)

• Postoperative complications

  Operation date till date of discharge until 52 weeks postoperatively

• Length of intensive care unit (ICU) and hospital stay

  Operation date till date of discharge until 52 weeks postoperatively

• In hospital mortality (IHM)

  Hospital admission period up to 90 days postoperatively

• Pathology results

  Up to 2 weeks postoperatively

• Survival

  5 years postoperatively

Study Arms (2)

Robot assisted minimally invasive esophagectomy

EXPERIMENTAL

Robot assisted minimally invasive esophagectomy

Procedure: Minimally invasive esophagectomy; Device: daVinci Xi system

Minimally invasive esophagectomy

ACTIVE COMPARATOR

Conventional minimally invasive esophagectomy

Procedure: Minimally invasive esophagectomy

Interventions

Minimally invasive esophagectomy PROCEDURE

Conventional minimally invasive esophagectomy

Minimally invasive esophagectomy; Robot assisted minimally invasive esophagectomy

daVinci Xi system DEVICE

robot assisted minimally invasive esophagectomy

Robot assisted minimally invasive esophagectomy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven adenocarcinoma of the intrathoracic esophagus and gastroesophageal junction (including Siewert I and II)
• Surgically resectable (T1-4a, N0-3, M0)
• Age ≥ 18 and ≤ 90 years
• European Clinical Oncology Group (ECOG) performance status 0,1 or 2
• Written informed consent

You may not qualify if:

• Esophageal squamous cell carcinoma
• Carcinoma of the cervical esophagus
• Carcinoma of the gastro-esophageal junction (GEJ) with the main part of the tumor in the gastric cardia (Siewert type III)
• Prior thoracic surgery at the right hemithorax or thoracic trauma

Sponsors & Collaborators

• University Medical Center Mainz: lead

Study Sites (1)

University Medical Center Mainz

Mainz, 55131, Germany

RECRUITING

Related Publications (1)

• Tagkalos E, van der Sluis PC, Berlth F, Poplawski A, Hadzijusufovic E, Lang H, van Berge Henegouwen MI, Gisbertz SS, Muller-Stich BP, Ruurda JP, Schiesser M, Schneider PM, van Hillegersberg R, Grimminger PP. Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus minimally invasive esophagectomy for resectable esophageal adenocarcinoma, a randomized controlled trial (ROBOT-2 trial). BMC Cancer. 2021 Sep 26;21(1):1060. doi: 10.1186/s12885-021-08780-x.

  PMID: 34565343 DERIVED

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus

Study Officials

• Peter Grimminger, MD,PhD

  JGU Medizin Mainz, dept. AVTC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pieter Christiaan van der Sluis, MD,PhD

CONTACT

+31628880709; p.c.vandersluis-2@umcutrecht.nl

Evangelos Tagkalos, MD

CONTACT

+4917673865294; evangelos.tagkalos@unimedizin-mainz.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Anonymous cases
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: Surgical RCT

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: March 13, 2020
• Study Start: January 18, 2021
• Primary Completion: May 19, 2023
• Study Completion (Estimated): January 19, 2028
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)