Proximal versus total gastrectomy for locally advanced Siewert type II–III gastroesophageal junction cancer
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 will see if keeping part of the stomach (proximal gastrectomy) or removing the whole stomach (total gastrectomy) leads to better 3-year disease-free survival for adults with locally advanced Siewert type II–III gastroesophageal junction cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Bakirkoy Dr. Sadi Konuk Research and Training Hospital Government |
| Locations | 1 site (Istanbul, Istanbul) |
| Trial ID | NCT07482566 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, prospective, randomized parallel trial comparing proximal gastrectomy and total gastrectomy with D2 lymphadenectomy in operable patients with locally advanced Siewert type II–III gastroesophageal junction cancer. Eligible patients are randomized to either procedure, which may be performed open, laparoscopically, or robotically according to surgeon judgment. The primary outcome is 3-year disease-free survival, with secondary outcomes including postoperative mortality, complications, and number of metastatic lymph nodes retrieved. Participants are followed for up to five years to capture long-term oncologic outcomes and perioperative morbidity.
Who should consider this trial
Good fit: Adults aged 18–90 with histologically confirmed, operable, locally advanced Siewert type II–III gastroesophageal junction cancer who are candidates for curative resection with D2 lymphadenectomy and can give informed consent.
Not a fit: Patients with early-stage tumors, cancers located in the antrum or corpus, those with prohibitive anesthetic risk (ASA IV or higher), or those unable to undergo D2 resection are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the trial could show that preserving part of the stomach provides similar cancer control but better postoperative function and lower morbidity than removing the whole stomach.
How similar studies have performed: Previous observational and smaller comparative studies have suggested improved functional outcomes after proximal gastrectomy but have produced mixed evidence on oncologic equivalence, and randomized data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Istanbul, Istanbul
- Bakirkoy Dr. Sadi Konuk Training and Research Hospital — Istanbul, Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Turgut Donmez, MD — Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Study coordinator: Turgut Donmez, MD
- Email: surgeont73@hotmail.com
- Phone: +90 5347400967
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.