Gastroesophageal Junction CancerSIEWERT-RCTNCT07482566
Proximal Versus Total Gastrectomy for Locally Advanced Siewert Type II-III Gastroesophageal Junction Cancer
A study testing Proximal Gastrectomy and Total Gastrectomy in people with Gastroesophageal Junction Cancer and Stomach Neoplasms, run by Nurettin Şahin at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastroesophageal Junction Cancer, Stomach Neoplasms, Esophageal Neoplasms
- What is being tested?
- Proximal Gastrectomy and Total Gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 1 Feb 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bakirkoy Dr. Sadi Konuk Training and Research Hospital
Istanbul, Istanbul, 34147
Turgut Donmez, MD, +905347400967, surgeont73@hotmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Proximal Gastrectomy, Total Gastrectomy
- Keywords
- Siewert Type II, Siewert Type III, Proximal Gastrectomy, Total Gastrectomy, Gastric Cancer Surgery
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal GastrectomyProcedure or surgery
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.
Total GastrectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Total Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-Year Disease-Free Survival
Disease-free survival defined as the time from surgery to tumor recurrence or death from any cause.
Measured: 3 years
Secondary outcomes (3)
Postoperative Mortality
All-cause mortality occurring within 90 days after surgery.
Measured: 90 days
Postoperative Complications
Incidence of postoperative complications including anastomotic leak, surgical site infection, bleeding, and pulmonary complications.
Measured: 90 days
Number of Metastatic Lymph Nodes
Total number of pathologically confirmed metastatic lymph nodes retrieved during surgery.
Measured: At time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 Feb 2026
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Junction CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nurettin Şahin
- Sponsor type
- Other government
- Collaborators
- Ankara City Hospital Bilkent, Bakirkoy Dr. Sadi Konuk Research and Training Hospital, Istanbul University - Cerrahpasa
- Responsible party
- Sponsor-investigator, Nurettin Şahin, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- Turgut Donmez, MD, Principal investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482566
- Sponsor's protocol ID
- SIEWERT-RCT-2026
- Acronym
- SIEWERT-RCT
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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. Can proximal gastrectomy with double-tract reconstruction replace total gastrectomy? a meta-analysis of randomized controlled trials and propensity score-matched studies. BMC Gastroenterol. 2024 Jul 23;24(1):230. doi: 10.1186/s12876-024-03323-7.
PubMed 39044132Yang X, Zeng Z, Liao Z, Zhu C, Wang H, Wu H, Cao S, Liang W, Li X. Comparison of proximal gastrectomy and total gastrectomy in proximal gastric cancer: a meta-analysis of postoperative health condition using the PGSAS-45. BMC Cancer. 2024 Oct 15;24(1):1282. doi: 10.1186/s12885-024-13046-3.
PubMed 39407137
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07482566
- Acronym / sponsor ID
- SIEWERT-RCT / SIEWERT-RCT-2026
- Keywords
- Siewert Type II, Siewert Type III, Proximal Gastrectomy, Total Gastrectomy, Gastric Cancer Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nurettin ŞahinOther government
- Collaborators
- Ankara City Hospital Bilkent, Bakirkoy Dr. Sadi Konuk Research and Training Hospital, Istanbul University - Cerrahpasa
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2033 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Proximal Gastrectomy | Experimental | Procedure: Proximal GastrectomyPatients 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. |
| Total Gastrectomy | Active comparator | Procedure: Total GastrectomyPatients 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proximal GastrectomyProximal 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. | Procedure or surgery | Proximal Gastrectomy |
| Total GastrectomyTotal 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. | Procedure or surgery | Total Gastrectomy |
Primary outcome
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 secondary outcomes
Postoperative Mortality
Time frame: 90 days
Postoperative Complications
Time frame: 90 days
Number of Metastatic Lymph Nodes
Time frame: At time of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Results publication: PubMed 39044132Zhu 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. Can proximal gastrectomy with double-tract reconstruction replace total gastrectomy? a meta-analysis of randomized controlled trials and propensity score-matched studies. BMC Gastroenterol. 2024 Jul 23;24(1):230. doi: 10.1186/s12876-024-03323-7.
- Results publication: PubMed 39407137Yang X, Zeng Z, Liao Z, Zhu C, Wang H, Wu H, Cao S, Liang W, Li X. Comparison of proximal gastrectomy and total gastrectomy in proximal gastric cancer: a meta-analysis of postoperative health condition using the PGSAS-45. BMC Cancer. 2024 Oct 15;24(1):1282. doi: 10.1186/s12885-024-13046-3.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Turgut Donmez, MD principal investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proximal Gastrectomy and Total Gastrectomy in people with Gastroesophageal Junction Cancer and Stomach Neoplasms, run by Nurettin Şahin at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Turgut Donmez, MD (+90 5347400967, surgeont73@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-Year Disease-Free Survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07482566, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.