cancer of the junction between stomach and esophagus siewert type 2 carcinoma true cardia carcinoma true cardia carcinoma, siewert type 2 carcinoma, cancer of thejunction between stomach and esophagu
Conditions
Interventions
The participants are randomized to either transthoracic esophagectomy or
transhiatal extended gastrectomy.
Sponsors
University of Cologne, Germany
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Principal inclusion criteria: • Histologically proven adenocarcinoma of the GEJ type II • Non distant metastatic tumor resectable by both transthoracic esophagectomy and transhiatal extended gastrectomy • Age >=18 • ECOG performance status
Exclusion criteria
Exclusion criteria: - Adenocarcinoma of the GEJ type I and III - Tumor resectable only by transthoracic esophagectomy or only by transhiatal extended gastrectomy - Positive lymph nodes only resectable by transthoracic esophagectomy (i.e. in the mid-upper mediastinum) or only resectable by transhiatal extended gastrectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The trial is powered to show superiority for esophagectomy with regards to the primary efficacy endpoint overall survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are complete resection (R0), number and localization of tumor infiltrated lymph nodes at dissection, post-operative complications, disease-free survival, quality of life and cost-effectiveness. Postoperative survival, disease-free survival and quality of life will be followed-up for 24 months after discharge. Further survival follow-up will be conducted as quarterly phone calls up to 60 months. | — |
Countries
France, Germany, Ireland, Netherlands, Sweden, Switzerland
Contacts
Public ContactGM Kuiper
Universitair Medisch Centrum Utrecht
Outcome results
None listed