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Gastric CancerPhase 2AaRonNCT02572050

Assessment of a Robotic Distal Gastrectomy on Non-inferiority of N2 Area Nodal Dissection

A Phase 2 study testing Distal Gastrectomy with D2 LND in people with Gastric Cancer, run by National Cancer Center, Korea at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
Distal Gastrectomy with D2 LND
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
2 sitesSouth Korea
Study dates
17 Aug 2015to 31 Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Performance status ≥3
  • 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.
  • Evidence of distant metastasis on clinical staging
  • Primary tumour deemed unresectable by operating surgeon
  • Inadequate organ function as below
Show all 10Show fewer
  • 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
  • Women of childbearing potential should have a negative pregnancy test within 7 days prior to commencing treatment, and must take adequate contraceptive precautions
  • Simultaneous participation in another clinical trial.

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • National Cancer Center of Korea

    Goyang-si, Gyeonggi-do, 10408

  • Aju University Hospital

    Suwon, Gyeonggi-do, 443-380

Other trials in South Korea

About this study

Official title: Assessment of a Robotic Distal Gastrectomy on Non-inferiority of N2 Area Nodal Dissection for Clinical Stage II or III Gastric Cancer

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.

Read the detailed description

The number of retrieved LNs in the N2 area after RDG is going to be calculated according to the pathology reports and comparative analysis to a historic group undergone open surgery for clinical stage II or III gastric cancer at the NCC Korea last year.

METHODS AGAINST BIAS Minimizing selection bias: After initiation of the study, all patients will be screened consecutively and all eligible patients will be asked to enrol in the trial. The trial is designed as a prospective multi-center phase II trial. Patients are going to be allocated to RAG after giving signed consent after sufficient consideration time.

Minimizing performance bias: The study is planned as a prospective single arm multi-center trial, as the retrospective data suggest that there is no disadvantage in lymph node retrieval after RAG compared to LAG. Surgery is going to be performed according to the guidelines of the Japanese Research Society for the Study of Gastric Cancer (3rd edition). Japanese randomized controlled trials have proven effectiveness of adequate D2 lymphadenectomy in several randomized controlled trials. As number of dissected lymph nodes is a surrogate marker for adequate lymph node dissection, only patients with at least 25 lymph nodes removed (as obtained from pathology report) will be definitively included in the data assessment. Further lymph node stations No. #7, #8a, #9, #11p, #12a for subtotal gastrectomy according to the Japanese Guideline have to be dissected out of the surgical specimen and analyzed separately in the pathologic workup. All patients in the trial are going to be analyzed, as success rate of LN dissection in the N2-area is the primary endpoint. Surgery in the trial must be performed by a board certified surgeon who has taken part in a trial specific training course. Potential learning curve artefacts are negligible because the RAG is going to be performed by surgeons who are highly trained and experienced in robotic gastrectomy.

Participating surgeons should have experience as an operator of over 50 cases of open gastrectomy, over 50 laparoscopic gastrectomy, and over 15 cases of robotic gastrectomy. Furthermore, surgical quality will have to be enforced by intraoperative video documentation. Also, pictures of nodal dissection area after resection should be submitted to have a quality assurance.

Minimizing detection bias: Patients are going to regularly undergo standardized follow-up visits at 6, 12, 18, 24, 30, 36, 48, 60 months to be evaluated disease status with abdominopelvic CT. EGD will be done on 3, 12, 24, 36, 48 and 60 months.

Conditions
Gastric Cancer
Being tested
Distal Gastrectomy with D2 LND
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Distal Gastrectomy with D2 LNDProcedure or surgery

    Also called Robotic Distal Gastrectomy with D2 LND

    Robotic Distal Gastrectomy with D2 lymphadenectomy(#7, #8a, #9, #11p, #12a in Japanese Classification) for patient with stage II or III gastric cancer

Study groups in NCT02572050
Study groupRoleWhat they receive
Robotic Distal Gastrectomy with D2 LNDExperimentalRobotic Distal Gastrectomy (RDG) with D2 LND for patient with stage II or III gastric cancer The primary efficacy endpoint of number of dissected lymph nodes in the N2 area (which is #7, #8a, #9, #11p and #12a according to the JRSSGC) after oncologic resection for clinical stage II or III gastric adenocarcinoma.assessment.
Receives: Procedure: Distal Gastrectomy with D2 LND

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Title: Number of retrieved lymph nodes in the topographical N2 area (#7, #8a, #9, #11p, #12a in Japanese Classification) after RDG for clinical stage II & III gastric cancer

    Evaluation of the number of retrieved lymph nodes in the topographical N2 area (#7, #8a, #9, #11p, #12a according to the Japanese Gastric Cancer Association classification) based on post-operative pathology reports as a surrogate parameter for adequate D2 lymphadenectomy after robot-assisted distal gastrectomy (RDG) in patients with clinical stage II or III gastric cancer.

    Measured: Within 30 days post-surgery (at post-operative pathological evaluation)

Secondary outcomes (8)

  1. 5-Year Overall Survival

    Evaluation of overall survival rate after 5 years of follow-up post-surgery calculated using Kaplan-Meier analysis

    Measured: 5 years post-surgery

  2. 3-Year Recurrence-Free Survival

    Evaluation of 3-year recurrence-free survival rate post-surgery calculated using Kaplan-Meier analysis, defined as the time from surgery to disease recurrence, secondary cancer, or death

    Measured: 3 years post-surgery

  3. Incidence of Local Recurrence

    Proportion of patients experiencing local tumor recurrence, confirmed by routine follow-up examinations including abdominopelvic CT, endoscopy, or biopsy

    Measured: Up to 5 years post-surgery

  4. Incidence of Distant Metastasis

    Proportion of patients experiencing distant tumor metastasis, evaluated through follow-up imaging (CT, PET) or tissue biopsy

    Measured: Up to 5 years post-surgery

  5. Incidence and Severity of Postoperative Complications

    Incidence and severity of early (within 30 days) and late (after 30 days) postoperative complications, classified according to the Clavien-Dindo Classification and scored using the Comprehensive Complication Index (CCI)

    Measured: Early complications (within 30 days post-surgery); Late complications (up to 5 years post-surgery)

  6. Total number of retrieved lymph nodes

    Total count of lymph nodes retrieved across all harvested stations based on post-operative pathology reports

    Measured: Within 30 days post-surgery (at post-operative pathological evaluation)

  7. Number of retrieved lymph nodes in the N1 area (#1, #3, #4sb, #4d, #5, #6 in Japanese Classification)

    Count of lymph nodes retrieved specifically from the N1 area stations (#1, #3, #4sb, #4d, #5, #6 according to Japanese Gastric Cancer Association classification) based on post-operative pathology reports

    Measured: Within 30 days post-surgery (at post-operative pathological evaluation)

  8. Quality of Life According to EQ-5D

    Assessment of patient quality of life evaluated using the EQ-5D questionnaire at designated follow-up intervals

    Measured: Baseline, 1 month, 6 months, and 1 year post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2015 (estimated)
  2. Study start17 Aug 2015
  3. Primary completion28 Jan 2021
  4. Study completion31 Jul 2026

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a prospective, multicenter, single-arm phase II clinical trial designed to evaluate the safety, feasibility, and thoroughness of robotic distal gastrectomy (RDG) with D2 lymph node dissection for patients with clinical stage II or III gastric adenocarcinoma . All enrolled, eligible participants are assigned to a single intervention arm to undergo robotic-assisted subtotal gastrectomy with standardized D2 lymphadenectomy * The study assesses whether RDG achieves non-inferiority in surgical quality compared to open surgery by using the number of retrieved lymph nodes in the topographical N2 area (#7, #8a, #9, #11p, and #12a according to the Japanese classification) as the primary surrogate endpoint Primary efficacy outcome data will be evaluated via a comparative analysis against a historical control group of patients who underwent conventional open subtotal gastrectomy for stage II or III gastric cancer at the National Cancer Center, Korea in 2014 . A total of 87 patients are
Masking
None (open label)
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02572050
Sponsor's protocol ID
NCC2015-0191
Acronym
AaRon
Status last verified
Oct 2026
First submitted
6 Oct 2015
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. doi: 10.1056/NEJMoa055531.

    PubMed 16822992

  • Song J, Oh SJ, Kang WH, Hyung WJ, Choi SH, Noh SH. Robot-assisted gastrectomy with lymph node dissection for gastric cancer: lessons learned from an initial 100 consecutive procedures. Ann Surg. 2009 Jun;249(6):927-32. doi: 10.1097/01.sla.0000351688.64999.73.

    PubMed 19474671

  • Woo Y, Hyung WJ, Pak KH, Inaba K, Obama K, Choi SH, Noh SH. Robotic gastrectomy as an oncologically sound alternative to laparoscopic resections for the treatment of early-stage gastric cancers. Arch Surg. 2011 Sep;146(9):1086-92. doi: 10.1001/archsurg.2011.114. Epub 2011 May 16.

    PubMed 21576595

  • Eom BW, Yoon HM, Ryu KW, Lee JH, Cho SJ, Lee JY, Kim CG, Choi IJ, Lee JS, Kook MC, Rhee JY, Park SR, Kim YW. Comparison of surgical performance and short-term clinical outcomes between laparoscopic and robotic surgery in distal gastric cancer. Eur J Surg Oncol. 2012 Jan;38(1):57-63. doi: 10.1016/j.ejso.2011.09.006. Epub 2011 Sep 25.

    PubMed 21945625

  • Yoon HM, Kim YW, Lee JH, Ryu KW, Eom BW, Park JY, Choi IJ, Kim CG, Lee JY, Cho SJ, Rho JY. Robot-assisted total gastrectomy is comparable with laparoscopically assisted total gastrectomy for early gastric cancer. Surg Endosc. 2012 May;26(5):1377-81. doi: 10.1007/s00464-011-2043-0. Epub 2011 Nov 16.

    PubMed 22083338

  • Kitano S, Shiraishi N, Uyama I, Sugihara K, Tanigawa N; Japanese Laparoscopic Surgery Study Group. A multicenter study on oncologic outcome of laparoscopic gastrectomy for early cancer in Japan. Ann Surg. 2007 Jan;245(1):68-72. doi: 10.1097/01.sla.0000225364.03133.f8.

    PubMed 17197967

  • Huscher CG, Mingoli A, Sgarzini G, Sansonetti A, Di Paola M, Recher A, Ponzano C. Laparoscopic versus open subtotal gastrectomy for distal gastric cancer: five-year results of a randomized prospective trial. Ann Surg. 2005 Feb;241(2):232-7. doi: 10.1097/01.sla.0000151892.35922.f2.

    PubMed 15650632

  • Noshiro H, Shimizu S, Nagai E, Ohuchida K, Tanaka M. Laparoscopy-assisted distal gastrectomy for early gastric cancer: is it beneficial for patients of heavier weight? Ann Surg. 2003 Nov;238(5):680-5. doi: 10.1097/01.sla.0000094302.51616.2a.

    PubMed 14578729

  • Kim YW, Baik YH, Yun YH, Nam BH, Kim DH, Choi IJ, Bae JM. Improved quality of life outcomes after laparoscopy-assisted distal gastrectomy for early gastric cancer: results of a prospective randomized clinical trial. Ann Surg. 2008 Nov;248(5):721-7. doi: 10.1097/SLA.0b013e318185e62e.

    PubMed 18948798

  • Uyama I, Kanaya S, Ishida Y, Inaba K, Suda K, Satoh S. Novel integrated robotic approach for suprapancreatic D2 nodal dissection for treating gastric cancer: technique and initial experience. World J Surg. 2012 Feb;36(2):331-7. doi: 10.1007/s00268-011-1352-8.

    PubMed 22131088

  • Sasako M, Sano T, Yamamoto S, Kurokawa Y, Nashimoto A, Kurita A, Hiratsuka M, Tsujinaka T, Kinoshita T, Arai K, Yamamura Y, Okajima K; Japan Clinical Oncology Group. D2 lymphadenectomy alone or with para-aortic nodal dissection for gastric cancer. N Engl J Med. 2008 Jul 31;359(5):453-62. doi: 10.1056/NEJMoa0707035.

    PubMed 18669424

  • Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K; ACTS-GC Group. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007 Nov 1;357(18):1810-20. doi: 10.1056/NEJMoa072252.

    PubMed 17978289

  • Lakatos E, Lan KK. A comparison of sample size methods for the logrank statistic. Stat Med. 1992 Jan 30;11(2):179-91. doi: 10.1002/sim.4780110205.

    PubMed 1579757

  • Com-Nougue C, Rodary C, Patte C. How to establish equivalence when data are censored: a randomized trial of treatments for B non-Hodgkin lymphoma. Stat Med. 1993 Jul 30;12(14):1353-64. doi: 10.1002/sim.4780121407.

    PubMed 8210831

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Distal Gastrectomy with D2 LND in people with Gastric Cancer, run by National Cancer Center, Korea at 2 sites in South Korea.

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 10 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: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Title: Number of retrieved lymph nodes in the topographical N2 area (#7, #8a, #9, #11p, #12a in Japanese Classification) after RDG for clinical stage II & III gastric cancer (time frame: Within 30 days post-surgery (at post-operative pathological evaluation)). 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 NCT02572050, which also lists 14 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 Oct 2026.

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