Comparing robot-assisted and conventional minimally invasive surgery for esophageal cancer
Official title: Robot-assisted Minimally Invasive Thoraco-laparoscopic Esophagectomy Versus Minimally Invasive Esophagectomy for Resectable Esophageal Cancer, a Randomized Controlled Trial (ROBOT-2 Trial).
Run by University Medical Center Mainz · NCT04306458 · Data updated 2026-11-12
This study is testing whether robot-assisted surgery is better than traditional minimally invasive surgery for patients with esophageal cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 218 (estimated) |
| Sponsor | University Medical Center Mainz Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Mainz) |
| Status | Recruiting |
| Started | January 18, 2021 |
| Main results expected | May 19, 2023 |
| Study ends | January 19, 2028 |
| Registry record updated | May 17, 2022 |
| Trial ID | NCT04306458 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 90 with histologically proven, surgically resectable esophageal adenocarcinoma.
✕Probably not a fit
Patients with esophageal squamous cell carcinoma or those who have had prior thoracic surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial evaluates the effectiveness of robot-assisted minimally invasive esophagectomy (RAMIE) compared to conventional minimally invasive esophagectomy (MIE) for patients with resectable esophageal adenocarcinoma. It is a multicenter randomized controlled trial that aims to assess lymph node dissection, efficacy, risks, quality of life, and cost-effectiveness of both surgical approaches. Patients aged 18 to 90 with histologically confirmed adenocarcinoma will be randomly assigned to receive either RAMIE or MIE. The study is conducted in accordance with ethical guidelines and aims to improve surgical outcomes for esophageal cancer patients.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for patients undergoing surgery for esophageal cancer.
How similar studies have gone: Previous studies have shown that both RAMIE and MIE are superior to open surgery, but this is the first randomized comparison between the two techniques.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
-
University Medical Center Mainz
Mainz, Germany Recruiting
Study contacts
- Principal investigator: Peter Grimminger, MD,PhD — JGU Medizin Mainz, dept. AVTC
- Study coordinator: Pieter Christiaan van der Sluis, MD,PhD
- Email: p.c.vandersluis-2@umcutrecht.nl
- Phone: +31628880709
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Adding 2141-V11 to standard therapy for advanced esophageal, gastric, or gastroesophageal junction cancer
This study tests whether adding the drug 2141-V11 to standard anti-PD-1 therapy (with or without 5-FU) is safe for adults with advanced or metastatic esophageal, gastric, or gastroesophageal junction adenocarcinoma.
-
Clonal Hematopoiesis Effects with Chemo and Radiation in Solid Cancers
This study tests whether clonal hematopoiesis affects outcomes for adults with solid cancers who are receiving chemotherapy or radiation.
-
Testing ctDNA to detect minimal residual disease in GI cancers
This study tests whether circulating tumor DNA can reveal minimal residual disease or early relapse in patients with esophageal, gastric, or pancreatic cancer who are receiving neoadjuvant or perioperative treatment.
-
Upfront Chemoradiation With Consolidation Chemotherapy for Localized Esophageal Adenocarcinoma
This study tests adding consolidative chemotherapy after chemoradiation to see if it better controls the cancer for people with localized esophageal adenocarcinoma who are candidates for chemoradiation.
-
DISP-10 for advanced colorectal, gastric, and esophageal cancers
This trial will test a one-time combination of an engineered adenovirus (DV-10) and BCMA-directed CAR T cells (ide-cel) in adults with advanced colorectal, gastric, or esophageal cancers.
-
Givastomig with nivolumab and chemotherapy for CLDN18.2-positive metastatic stomach or gastroesophageal junction cancer
This study will see if adding givastomig to nivolumab plus standard chemotherapy helps adults with CLDN18.2- and PD-L1-positive metastatic stomach or gastroesophageal junction cancer live longer without their disease getting worse.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.