C16.0
Conditions
Interventions
Group 1: Transthoracic esophagectomy (removal of the esophagus and intrathoracic connection of the esophagus to the stomach)
Group 2: Transhiatal extended gastrectomy (Removal of the stomach and the l
Sponsors
Universitätsklinik Köln Klinik und Poliklinik für Allgemein- Viszeral- und Tumorchirurgie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Histologically proven adenocarcinoma of the GEJ type II • Non-metastatic tumor, resectable by both transthoracic esophagectomy and transhiatal extended gastrectomy according to the local surgical investigator • Age = 18 • ECOG Eastern Cooperative Oncology Group (ECOG) performance status 0–2 • ASA 50% (determined by echocardiography) • Adequate respiratory function (pulmonary function tests only necessary in symptomatic patients) with FEV1>/= 1.5 l/s • Adequate bone marrow function (white blood cells > 3x10^9 /l; hemoglobin > 9 g/dl; platelets > 100x10^9 /l), renal function (glomerular filtration rate >60 ml/min), and liver function (total bilirubin < 1.5x upper level of normal (ULN), aspartate transaminase (AST) < 2.5x ULN and alanine transaminase (ALT) < 3x ULN) • Written informed consent
Exclusion criteria
Exclusion criteria: • Tumors of squamous, adenosquamous or another non-adenocarcinoma histology • Advanced inoperable or metastatic GEJ type II adenocarcinoma • GEJ type II adenocarcinoma staged cT4b, M+ • GEJ type II cT4a evaluated as not curatively resectable by the local surgical investigator • Histologically proven adenocarcinoma of the GEJ type I and III • Severe tumor stenosis preventing endoscopic tumor classification • Tumor expanding more than 5 cm proximal of the GEJ • Tumor resectable only by transthoracic esophagectomy or only by transhiatal extended gastrectomy, according to the local surgical investigator • Positive lymph nodes only resectable by transthoracic esophagectomy (i.e. in the mid-upper mediastinum) or only resectable by transhiatal extended gastrectomy according to the local surgical investigator. • Patients with locally advanced tumors (T3-T4 or N+) who did not receive chemotherapy (FLOT) preoperatively or received more or less than the allowed 4 cycles of chemotherapy • Clinically significant (active) cardiac disease (e.g. symptomatic coronary artery disease or myocardial infarction within last 12 months) • Clinically significant lung disease (forced expiratory volume in one second (FEV1) < 1.5 l/s) • Pregnant women and nursing mothers • Persons with any kind of dependency on the principal investigator or employed by the sponsor or principal investigator • Legally incapacitated persons • Persons held in an institution by legal or official order
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (Follow-up up to 60 months after discharge) | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete (R0) resection, post-operative complications according to the Dindo-Clavien classification, number and Tumor Infiltration of lymph nodes at dissection, quality of life (EORTC QLQ-C30, -STO22, -OG25 after 3, 6, 12, 18, 24 months), cost-effectiveness | — |
Countries
Germany, Netherlands
Contacts
Public ContactChristiane Bruns
Universitätsklinik Köln Klinik und Poliklinik für Allgemein- Viszeral- und Tumorchirurgie
Outcome results
None listed