DRKS00016923招募中4 期

Surgery for adenocarcinoma of the gastroesophageal junction (GEJ) type II:Transthoracic esophagectomy vs. transhiatal extended gastrectomy. - CARDIA Trial

niversitätsklinik Köln Klinik und Poliklinik für Allgemein- Viszeral- und Tumorchirurgie0 个研究点目标入组 262 人开始时间: 2019年8月2日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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 < 4.
•Pre-treatment stage cT1-4a N0/N+, M0
•In case of stage cT4a, curative resectability must be explicitly verified by the local surgical investigator prior to randomization
•Patients with locally advanced tumors (T3-T4 or N+) who received four cycles of chemotherapy (FLOT) preoperatively
•Negative serum pregnancy test during screening period for women of child-bearing age
•Patients with a cardiac history should receive a cardiology consultation and should have a left ventricular ejection fraction > 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

•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

发起方

niversitätsklinik Köln Klinik und Poliklinik für Allgemein- Viszeral- und Tumorchirurgie