The comparison of surgical therapies for adenocarcinoma of the gastroesophageal junction: transthoracic esophagectomy versus transhiatal extended gastrectomy
Zusammenfassung der Studie
This study investigates the best possible surgical therapy for tumors located at the junction of the esophagus and stomach. Esophageal tumors are typically surgically treated by "esophagectomy" with stomach elevation. In this procedure, a large part of the esophagus along with the esophageal-stomach junction is removed. The stomach is shaped into a tube through an abdominal access, which is then connected to the remaining esophagus via a thoracic access. For tumors in the stomach, a "transhiatal extended gastrectomy" is performed. In this procedure, the entire stomach along with the esophageal-stomach junction is removed through an abdominal access, and a connection between the esophagus and small intestine is established. It remains unclear which procedure is best for tumors at the junction between the esophagus and stomach. Both procedures allow for complete tumor removal and are recommended in current treatment guidelines as equivalent treatment methods. The aim of the CARDIA study is to compare the two surgical approaches in terms of healing rates and resulting quality of life. This should enable the best possible surgical procedure to be offered to all patients with tumors of the esophageal-stomach junction.
(BASEC)
Untersuchte Intervention
This study compares "esophagectomy" with stomach elevation and "transhiatal extended gastrectomy". In "esophagectomy", which is the removal of the esophagus, the upper part of the stomach as well as a large part of the esophagus is removed. To restore continuity, a tube is formed from the remaining stomach, which is pulled into the thoracic cavity and connected to the remaining part of the esophagus. Access is achieved through both the abdominal cavity and the thoracic cavity. In "gastrectomy", which is the removal of the stomach, the entire stomach as well as the lower part of the esophagus is removed. To restore continuity, the remaining end of the esophagus is connected to the small intestine. Access is achieved in this procedure only through the abdominal cavity.
(BASEC)
Untersuchte Krankheit(en)
This study investigates esophageal carcinomas. Their incidence has significantly increased in recent decades. This study focuses on so-called "adenocarcinomas", which are malignant tumors arising from glandular epithelial cells. A particular form of these carcinomas involves tumors at the junction of the esophagus and stomach. In most cases, these tumors are treated with a combination of chemotherapy, possibly with radiation, followed by surgery.
(BASEC)
Patients with an adenocarcinoma of the gastroesophageal junction type II are included. The tumor and any affected lymph nodes must be removable by both transthoracic esophagectomy and transhiatal extended gastrectomy. Furthermore, patients must be in good condition, i.e., have good heart, lung, kidney, and liver function. For women of childbearing age, a negative pregnancy test must be present. Of course, a written consent form must also be provided.
(BASEC)
Ausschlusskriterien
Patients with another type of tumor or tumor localization are excluded. Additionally, patients with surgically unresectable tumors or distant metastases (e.g., in the liver) are excluded. Furthermore, patients with clinically significant heart or lung diseases are excluded.
(BASEC)
Studienstandort
Basel
(BASEC)
Sponsor
Sponsor: University of Cologne, Germany Sponsor's representative in Switzerland: Clarunis - Universitäres Bauchzentrum Basel
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Beat Müller
0041-61-777-75-75
viszeralchirurgie@clutterclarunis.chClarunis - Universitäres Bauchzentrum Basel
(BASEC)
Allgemeine Auskünfte
Universitätsklinik Köln Klinik und Poliklinik für Allgemein- Viszeral- und Tumorchirurgie
+49-221-478-4801
cardia.trial@uk-koeln.de(ICTRP)
Wissenschaftliche Auskünfte
Universitätsklinik Köln Klinik und Poliklinik für Allgemein- Viszeral- und Tumorchirurgie
+49-221-478-4801
cardia.trial@uk-koeln.de(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
03.08.2023
(BASEC)
ICTRP Studien-ID
DRKS00016923 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Surgery for adenocarcinoma of the gastroesophageal junction (GEJ) type II: Transthoracic esophagectomy vs. transhiatal extended gastrectomy (BASEC)
Wissenschaftlicher Titel
Surgery for adenocarcinoma of the gastroesophageal junction (GEJ) type II:Transthoracic esophagectomy vs. transhiatal extended gastrectomy. - CARDIA Trial (ICTRP)
Öffentlicher Titel
Surgery for adenocarcinoma of the gastroesophageal junction (GEJ) type II:Transthoracic esophagectomy vs. transhiatal extended gastrectomy. (ICTRP)
Untersuchte Krankheit(en)
;C16.0 - Malignant neoplasm: Cardia
(ICTRP)
Untersuchte Intervention
Intervention 1: Transthoracic esophagectomy (removal of the esophagus and intrathoracic connection of the esophagus to the stomach) Intervention 2: Transhiatal extended gastrectomy (Removal of the stomach and the lower part of the esophagus with esophageal jejunostomy)
(ICTRP)
Studientyp
interventional (ICTRP)
Studiendesign
Allocation: Randomized controlled trial;. Masking: Open (masking not used). Control: Active control (effective treament of control group). Assignment: Parallel. Study design purpose: Treatment;
(ICTRP)
Ein-/Ausschlusskriterien
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
(ICTRP)
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
(ICTRP)
Primäre und sekundäre Endpunkte
Overall survival (Follow-up up to 60 months after discharge)
(ICTRP)
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
(ICTRP)
Registrierungsdatum
02.08.2019 (ICTRP)
Einschluss des ersten Teilnehmers
16.04.2020 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Christiane Bruns, cardia.trial@uk-koeln.de, +49-221-478-4801, Universitätsklinik Köln Klinik und Poliklinik für Allgemein- Viszeral- und Tumorchirurgie (ICTRP)
Sekundäre IDs
19-1376 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
No
(ICTRP)
Weitere Informationen zur Studie
http://www.drks.de/DRKS00016923 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar