Status:
RECRUITING
RAMIE Versus MIE for Resectable Esophageal Cancer, a Randomized Controlled Trial (ROBOT-2 Trial).
Lead Sponsor:
University Medical Center Mainz
Conditions:
Esophageal Adenocarcinoma
Eligibility:
All Genders
18-90 years
Phase:
NA
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...
Detailed Description
Aim of the study This is a randomized controlled parallel-group, superiority trial comparing RAMIE to MIE with intrathoracic anastomosis (Ivor-Lewis) in patients with resectable esophageal adenocarcin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 19 2028
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT04306458
Start Date
January 18 2021
End Date
January 19 2028
Last Update
May 17 2022
Active Locations (1)
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1
University Medical Center Mainz
Mainz, Germany, 55131