Proximal Versus Total Gastrectomy for Locally Advanced Siewert Type II-III Gastroesophageal Junction Cancer

NCT07482566 | Recruiting

• 1 other identifier: SIEWERT-RCT-2026
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastroesophageal Junction Cancer; Stomach Neoplasms; Esophageal Neoplasms

Keywords

Siewert Type II; Siewert Type III; Proximal Gastrectomy; Total Gastrectomy; Gastric Cancer Surgery

Outcome Measures

Primary Outcomes (1)

• 3-Year Disease-Free Survival

  Disease-free survival defined as the time from surgery to tumor recurrence or death from any cause.

  3 years

Secondary Outcomes (3)

• Postoperative Mortality

  90 days

• Postoperative Complications

  90 days

• Number of Metastatic Lymph Nodes

  At time of surgery

Study Arms (2)

Proximal Gastrectomy

EXPERIMENTAL

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

Total Gastrectomy

ACTIVE COMPARATOR

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

Interventions

Proximal Gastrectomy PROCEDURE

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.

Proximal Gastrectomy

Total Gastrectomy PROCEDURE

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.

Total Gastrectomy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nurettin Şahin: lead
• Ankara City Hospital Bilkent: collaborator
• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: collaborator
• Istanbul University - Cerrahpasa: collaborator

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Istanbul, Istanbul, 34147, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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

  RESULT

• Yang X,Zeng Z,Liao Z,Zhu C,Wang H,Wu H,Cao S,Liang W,Li X

  RESULT

MeSH Terms

Conditions

Stomach Neoplasms; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases

Study Officials

• Turgut Donmez, MD

  Bakirkoy Dr. Sadi Konuk Research and Training Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Turgut Donmez, MD

CONTACT

+90 5347400967; surgeont73@hotmail.com

Tolga Dinc, MD

CONTACT

+90 5324812275; tolga_dr@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of surgical interventions, surgeons and patients cannot be fully blinded to the procedure. However, outcome assessment and data analysis will be performed by independent investigators who are blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized in a parallel design to undergo either proximal gastrectomy or total gastrectomy with D2 lymphadenectomy. Surgical approach (open, laparoscopic, or robotic) will be selected according to patient suitability and surgeon preference.

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: March 19, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2033
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

TU (1)