Proximal Versus Total Gastrectomy for Locally Advanced Siewert Type II-III Gastroesophageal Junction Cancer (SIEWERT-RCT)

March 18, 2026 updated by: Nurettin Şahin

A Multicenter Prospective Randomized Double-Blind Clinical Trial Comparing Proximal Gastrectomy and Total Gastrectomy in Patients With Locally Advanced Siewert Type II-III Gastroesophageal Junction Cancer

This multicenter prospective randomized clinical trial aims to compare the safety and oncological effectiveness of proximal gastrectomy and total gastrectomy in patients with locally advanced Siewert type II-III gastroesophageal junction cancer. Eligible patients will be randomly assigned to undergo either proximal gastrectomy or total gastrectomy using open, laparoscopic, or robotic surgical approaches according to clinical suitability. The primary outcome of the study is 3-year disease-free survival. Secondary outcomes include postoperative mortality, postoperative complications, and the number of metastatic lymph nodes retrieved. Patients will be followed for up to five years after surgery to evaluate long-term oncological outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Gastroesophageal junction cancers represent a challenging oncological entity, particularly in patients with locally advanced Siewert type II-III tumors. Total gastrectomy has traditionally been considered the standard surgical treatment; however, proximal gastrectomy has gained increasing interest in recent years due to potential advantages in postoperative functional outcomes and reduced surgical morbidity. Nevertheless, concerns remain regarding the adequacy of oncological clearance and lymph node dissection with proximal gastrectomy.

This multicenter prospective randomized clinical trial is designed to evaluate the safety, feasibility, and oncological outcomes of proximal gastrectomy compared with total gastrectomy in patients with locally advanced Siewert type II-III gastroesophageal junction cancer. Patients diagnosed through endoscopic and histopathological evaluation and deemed operable after multidisciplinary tumor board discussion will be included. Following informed consent, participants will be randomized in a parallel design to undergo either proximal gastrectomy or total gastrectomy with D2 lymph node dissection (D2 lymphadenectomy). Surgical procedures may be performed via open, laparoscopic, or robotic approaches based on surgeon preference and patient suitability.

Baseline demographic characteristics, perioperative variables, pathological findings, postoperative morbidity and mortality, and long-term oncological outcomes will be prospectively recorded. The primary endpoint is 3-year disease-free survival (DFS), while secondary endpoints include postoperative complications, mortality, and the number of metastatic lymph nodes. Patients will be followed at predefined intervals for up to five years after surgery. The results of this study are expected to provide high-level evidence to guide surgical decision-making in the management of locally advanced gastroesophageal junction cancers.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34147
        • Recruiting
        • Bakirkoy Dr. Sadi Konuk Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18 and 90 years
  • Histologically confirmed locally advanced Siewert type II-III gastroesophageal junction cancer
  • Considered operable after multidisciplinary tumor board evaluation
  • Candidate for curative surgical resection with D2 lymphadenectomy
  • Provision of written informed consent

Exclusion Criteria:

  • Early-stage gastroesophageal junction cancer
  • Gastric cancers located in the antrum or corpus
  • Severe anesthetic risk (American Society of Anesthesiologists [ASA] class IV or higher)
  • Pregnancy
  • Patients unwilling or unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Proximal Gastrectomy
Patients randomized to this arm will undergo proximal gastrectomy with D2 lymphadenectomy. The surgical approach (open, laparoscopic, or robotic) will be selected according to patient suitability and surgeon preference.
Procedure: Proximal Gastrectomy
Proximal gastrectomy with D2 lymphadenectomy involving resection of the proximal stomach and gastroesophageal junction. Reconstruction will be performed using esophagogastric or esophagojejunal anastomosis according to surgeon preference. The procedure may be performed via open, laparoscopic, or robotic approach depending on patient suitability.
Active Comparator: Total Gastrectomy
Patients randomized to this arm will undergo total gastrectomy with D2 lymphadenectomy. The surgical approach (open, laparoscopic, or robotic) will be selected according to patient suitability and surgeon preference.
Procedure: Total Gastrectomy
Total gastrectomy with D2 lymphadenectomy involving complete removal of the stomach followed by esophagojejunal reconstruction. The surgical approach (open, laparoscopic, or robotic) will be selected according to patient suitability and surgeon preference.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-Year Disease-Free Survival
Time Frame: 3 years
Disease-free survival defined as the time from surgery to tumor recurrence or death from any cause.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Mortality
Time Frame: 90 days
All-cause mortality occurring within 90 days after surgery.
90 days
Postoperative Complications
Time Frame: 90 days
Incidence of postoperative complications including anastomotic leak, surgical site infection, bleeding, and pulmonary complications.
90 days
Number of Metastatic Lymph Nodes
Time Frame: At time of surgery
Total number of pathologically confirmed metastatic lymph nodes retrieved during surgery.
At time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nurettin Şahin

Collaborators

Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Ankara City Hospital Bilkent
Istanbul University - Cerrahpasa

Investigators

  • Principal Investigator: Turgut Donmez, MD, Bakırköy Dr. Sadi Konuk Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Zhu G,Jiao X,Zhou S,Zhu Q,Yu L,Sun Q,Li B,Fu H,Huang J,Lang W,Lang X,Zhai S,Xiong J,Fu Y,Liu C,Qu J
  • Yang X,Zeng Z,Liao Z,Zhu C,Wang H,Wu H,Cao S,Liang W,Li X

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2033

Study Registration Dates

First Submitted

March 15, 2026

First Submitted That Met QC Criteria

March 15, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIEWERT-RCT-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

De-identified individual participant data, including baseline characteristics, perioperative variables, pathological findings, and analyzable outcome data, may be shared with qualified researchers after completion of the study and publication of the primary results. Data sharing will be subject to institutional policies, ethical approvals, and applicable data protection regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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