NCT02572050

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
87

participants targeted

Target at P50-P75 for phase_2 gastric-cancer

Timeline
Completed

Started Oct 2015

Longer than P75 for phase_2 gastric-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

1.2 years

First QC Date

October 6, 2015

Last Update Submit

April 18, 2016

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of retrieved lymph nodes in the topographical N2 area

    Number of retrieved lymph nodes in the topographical N2 area (#7, #8a, #9, #11p, #12a in Japanese Classification)

    1 week

Secondary Outcomes (6)

  • Overall-survival

    five years

  • Recurrence-free survival

    Three Year

  • Incidence of local recurrence

    Five Year

  • Early Complications

    1 month

  • Late Complications

    5 year

  • +1 more secondary outcomes

Study Arms (1)

Robotic Distal Gastrectomy with D2 LND

EXPERIMENTAL

Robotic 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.

Procedure: Distal Gastrectomy with D2 LND

Interventions

Distal Gastrectomy with D2 LNDPROCEDURE

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

Also known as: Robotic Distal Gastrectomy with D2 LND
Robotic Distal Gastrectomy with D2 LND

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Performance status ≥3
  • Patients not eligible for surgery (ASA \>=4)
  • Evidence of distant metastasis on clinical staging
  • Primary tumour deemed unresectable by operating surgeon
  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Cancer Center of Korea

Goyang-si, Gyeonggi-do, 10408, South Korea

RECRUITING

Aju University Hospital

Suwon, Gyeonggi-do, 443-380, South Korea

RECRUITING

Related Publications (14)

  • 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.

    PMID: 16822992BACKGROUND

  • 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.

    PMID: 19474671RESULT

  • 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.

    PMID: 21576595RESULT

  • 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.

    PMID: 21945625RESULT

  • 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.

    PMID: 22083338RESULT

  • 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.

    PMID: 17197967RESULT

  • 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.

    PMID: 15650632RESULT

  • 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.

    PMID: 14578729RESULT

  • 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.

    PMID: 18948798RESULT

  • 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.

    PMID: 22131088RESULT

  • 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.

    PMID: 18669424RESULT

  • 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.

    PMID: 17978289RESULT

  • 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.

    PMID: 1579757RESULT

  • 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.

    PMID: 8210831RESULT

Related Links

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Gastroenterostomy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Anastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Young-Woo Kim, PhD

    National Cancer Center of Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Young-Woo Kim, PhD

CONTACT

+821088691635gskim@ncc.re.kr

Hong Man Yoon, PhD

CONTACT

+821063568426red10000@ncc.re.kr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 6, 2015

First Posted

October 8, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2021

Last Updated

April 20, 2016

Record last verified: 2016-04

Locations

KR(2)