The aim of the study is to compare transthoracic esophagectomy versus transhiatal extended gastrectomy in patients with GEJ type II tumors. It is hypothesized that esophagectomy allows for a higher rate of radical resections and a more complete…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The trial is powered to show superiority for esophagectomy with regards to the
primary efficacy endpoint overall survival.
Secondary outcome
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.
Background summary
Adenocarcinoma of the gastroesophageal junction (GEJ) Siewert type II can be
resected by transthoracic esophagectomy or transhiatal extended gastrectomy.
Both allow for a complete tumor resection, yet there is an ongoing controversy
about which surgical approach is superior with regards to quality of life,
oncological outcomes and survival. While some studies suggest a better
oncological outcome after transthoracic esophagectomy, others favor transhiatal
extended gastrectomy for a better postoperative quality of life. To date, only
retrospective studies are available, showing ambiguous results.
Study objective
The aim of the study is to compare transthoracic esophagectomy versus
transhiatal extended gastrectomy in patients with GEJ type II tumors. It is
hypothesized that esophagectomy allows for a higher rate of radical resections
and a more complete mediastinal lymph node dissection, resulting in a longer
overall survival, while still providing an acceptable quality of life and an
acceptable cost-effectiveness.
Study design
This study is a non-blinded, multinational, multicenter, prospective,
randomized controlled superiority trial.
Intervention
The participants are randomized to either transthoracic esophagectomy or
transhiatal extended gastrectomy.
Study burden and risks
Both operations are procedures that are recommended in the Dutch guidelines
(oncoline.nl) and the German S3 guidelines as standard therapy for the
investigated tumor disease, there is neither an additional risk nor a direct
benefit for the participating patients. We would classify the current study as
neglectable risk. Compared to standard care, te additional burden for patients
consists of filling in 8 quality of life questionnaires over the course of 2
years, each of which takes 15-30 minutes to complete.
Kerpener Strasse 62
Cologne 50937
DE
Kerpener Strasse 62
Cologne 50937
DE
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | Deutsches Register Klinischer Studien. DRKS-number: 00016923 |
| CCMO | NL73053.041.20 |