Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:57 AM
Study NCT ID:
NCT07482566
Status:
RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proximal Versus Total Gastrectomy for Locally Advanced Siewert Type II-III Gastroesophageal Junction Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2033-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-15', 'studyFirstSubmitQcDate': '2026-03-15', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-Year Disease-Free Survival', 'timeFrame': '3 years', 'description': 'Disease-free survival defined as the time from surgery to tumor recurrence or death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Postoperative Mortality', 'timeFrame': '90 days', 'description': 'All-cause mortality occurring within 90 days after surgery.'}, {'measure': 'Postoperative Complications', 'timeFrame': '90 days', 'description': 'Incidence of postoperative complications including anastomotic leak, surgical site infection, bleeding, and pulmonary complications.'}, {'measure': 'Number of Metastatic Lymph Nodes', 'timeFrame': 'At time of surgery', 'description': 'Total number of pathologically confirmed metastatic lymph nodes retrieved during surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Siewert Type II', 'Siewert Type III', 'Proximal Gastrectomy', 'Total Gastrectomy', 'Gastric Cancer Surgery'], 'conditions': ['Gastroesophageal Junction Cancer', 'Stomach Neoplasms', 'Esophageal Neoplasms']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': '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'}, {'type': 'RESULT', 'citation': 'Yang X,Zeng Z,Liao Z,Zhu C,Wang H,Wu H,Cao S,Liang W,Li X'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.\n\nBaseline 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 90 years\n* Histologically confirmed locally advanced Siewert type II-III gastroesophageal junction cancer\n* Considered operable after multidisciplinary tumor board evaluation\n* Candidate for curative surgical resection with D2 lymphadenectomy\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Early-stage gastroesophageal junction cancer\n* Gastric cancers located in the antrum or corpus\n* Severe anesthetic risk (American Society of Anesthesiologists \\[ASA\\] class IV or higher)\n* Pregnancy\n* Patients unwilling or unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT07482566', 'acronym': 'SIEWERT-RCT', 'briefTitle': 'Proximal Versus Total Gastrectomy for Locally Advanced Siewert Type II-III Gastroesophageal Junction Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'SIEWERT-RCT-2026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Proximal Gastrectomy', 'description': '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.', 'interventionNames': ['Procedure: Proximal Gastrectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Total Gastrectomy', 'description': '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.', 'interventionNames': ['Procedure: Total Gastrectomy']}], 'interventions': [{'name': 'Proximal Gastrectomy', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Proximal Gastrectomy']}, {'name': 'Total Gastrectomy', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Total Gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34147', 'city': 'Istanbul', 'state': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Turgut Donmez, MD', 'role': 'CONTACT', 'email': 'surgeont73@hotmail.com', 'phone': '+905347400967'}], 'facility': 'Bakirkoy Dr. Sadi Konuk Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Turgut Donmez, MD', 'role': 'CONTACT', 'email': 'surgeont73@hotmail.com', 'phone': '+90 5347400967'}, {'name': 'Tolga Dinc, MD', 'role': 'CONTACT', 'email': 'tolga_dr@hotmail.com', 'phone': '+90 5324812275'}], 'overallOfficials': [{'name': 'Turgut Donmez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bakırköy Dr. Sadi Konuk Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nurettin Şahin', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, {'name': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital', 'class': 'OTHER_GOV'}, {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nurettin Şahin', 'investigatorAffiliation': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}}}}