NCT02572050CompletedPhase 2
Assessment of a Robotic Distal Gastrectomy on Non-inferiority of N2 Area Nodal Dissection
Assessment of a Robotic Distal Gastrectomy on Non-inferiority of N2 Area Nodal Dissection for Clinical Stage II or III Gastric Cancer
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
Designed as a single arm multi-center prospective phase II trial, which evaluates the number of dissected lymph nodes in the N2-area as a surrogate parameter for adequate D2 lymphadenectomy in robotic distal gastrectomy (RDG) for clinical stage II or III gastric cancer.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 87 (actual)
- First submitted
- 6 Oct 2015
- Start date
- 17 Aug 2015
- Primary completion date
- 28 Jan 2021
- Lead sponsor
- National Cancer Center, Korea
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT02572050
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 87
- From 17 Aug 2015 to the primary completion date, 28 Jan 2021
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients not eligible for surgery (ASA \>=4)
- History of another primary cancer, except curatively treated in situ cervical cancer, curatively resected non-melanoma skin cancer. The inclusion of patients with other types of cancer that were successfully treated and did not recur within the last 5 years prior to study enrolment have to be discussed with the principal investigator.
- Women of childbearing potential should have a negative pregnancy test within 7 days prior to commencing treatment, and must take adequate contraceptive precautions
Lab values
- Inadequate organ function as below
- Bone marrow function defined as: (ANC ≤1.0x109/l, WBC (total) ≤ 2.5x109/l, Platelet Count ≤ 70x109/l, Haemoglobin ≤ 8 g/dl (can be post-transfusion)
- Renal function with serum Creatinine ≥1.5 mg/dL) ③ Liver function defined as (Total Bilirubin≥ 2.0x (ULN), ALT/AST ≥2.5x ULN) ④ Coagulation profile: with PT (INR) ≥1.5, aPTT(sec) ≥1.5xULN
Other
- Performance status ≥3
- Evidence of distant metastasis on clinical staging
- Primary tumour deemed unresectable by operating surgeon
- Simultaneous participation in another clinical trial.
Who the study is looking for
- Histologically proven adenocarcinoma of the stomach in patients that have not received any previous treatment for their cancer
- Tumours should be stage II or III according to the UICC 7th edition with no sign of distant metastasis and deemed resectable (R0) by the operating surgeon on preoperative staging by EGD, and CT of abdomen and pelvis
- Location of the tumor at the pylorus, antrum, angle, lower body and midbody to allow subtotal gastrectomy
- Age ≥ 19 years
- Written informed consent
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center of Korea Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Aju University Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.