SURGERY FOR ADENOCARCINOMA OF THE GASTROESOPHAGEAL JUNCTION (GEJ) TYPE II: TRANSTHORACIC ESOPHAGECTOMY VS. TRANSHIATAL EXTENDED GASTRECTOMY (CARDIA trial)

Recruiting

Conditions: 10017991
10017998
cancer of the junction between stomach and esophagus
siewert type 2 carcinoma
true cardia carcinoma
10017990

Registration Number: NL-OMON52610

Lead Sponsor: niversity of Cologne, Germany

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

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 < 3
• ASA <4
• Patients with locally advanced tumors (T3-T4 or N+) who received at least one
cycle of chemotherapy (FLOT) preoperatively

Principal 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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The trial is powered to show superiority for esophagectomy with regards to the<br /><br>primary efficacy endpoint overall survival.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are complete resection (R0), number and localization of<br /><br>tumor infiltrated lymph nodes at dissection, post-operative complications,<br /><br>disease-free survival, quality of life and cost-effectiveness. Postoperative<br /><br>survival, disease-free survival and quality of life will be followed-up for 24<br /><br>months after discharge. Further survival follow-up will be conducted as<br /><br>quarterly phone calls up to 60 months.</p><br>