Robot-assisted Minimally Invasive Thoraco-laparoscopic Esophagectomy Versus Minimally Invasive Esophagectomy for Resectable Esophageal Cancer, a Randomized Controlled Trial (ROBOT-2 Trial).

Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
University Medical Center Mainz
RECRUITING
Mainz
Contact Information
Primary
Pieter Christiaan van der Sluis, MD,PhD
p.c.vandersluis-2@umcutrecht.nl
+31628880709
Backup
Evangelos Tagkalos, MD
evangelos.tagkalos@unimedizin-mainz.de
+4917673865294
Time Frame
Start Date: 2021-01-18
Estimated Completion Date: 2028-01-19
Participants
Target number of participants: 218
Treatments
Experimental: Robot assisted minimally invasive esophagectomy
Robot assisted minimally invasive esophagectomy
Active_comparator: Minimally invasive esophagectomy
Conventional minimally invasive esophagectomy
Related Therapeutic Areas
Sponsors
Leads: University Medical Center Mainz

This content was sourced from clinicaltrials.gov