Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy

Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy and Stomach Preserving Surgery in Early Gastric Cancer

Laparoscopic sentinel lymph node biopsy and stomach preserving surgery in early gastric cancer is less invasive method which can increase quality of life. For last two years, multicenter quality control study (Phase II) has been performed in Korea and tolerable results were observed. Based on these results, multicenter phase III trial is required to validate the clinical role of laparoscopic sentinel lymph node biopsy.

Study Overview

• Status: Completed
• Conditions: Early Gastric Cancer
• Intervention / Treatment: Procedure: Laparoscopic Sentinel Node Biopsy; Procedure: Laparoscopy Assisted Gastrectomy

Detailed Description

The final analyses include the modified intention to treatment analysis (full analysis set) and Per Protocol analysis (including patients who underwent assigned surgery without agreement withdrawal).

1. Injection of tracer and sentinel basin dissection

   • Tracer: Tc 99m HSA (Human serum albumin, 2ml, 0.1mCi/ml) + ICG (indocyanine green, 2ml, 5mg/ml)
   • Endoscopic injection of tracer on 4 sites around gastric cancer
   • Identification of sentinel basin using laparoscopic probe (Neoprobe)
   • Laparoscopic sentinel basin dissection and identification of sentinel node at back table

2. Surgical considerations

   • If positive sentinel nodes were diagnosed in frozen section, conventional gastrectomy is performed.
   • If micrometastasis or isolate tumor cells in sentinel basin lymph nodes were diagnosed in the permanent pathology, re-operation of conventional gastrectomy is not performed.
   • However, re-operation of converntional gastrectomy should be performed in case of macrometastasis, deep and lateral margin positive, more than pT2 lesion in the permanent pathology.
3. H.pylori eradication - There was no clear evidence that H.pylori eradication reduced development of metachronous gastric cancer. H.pylori eradication was planned to perform according to physician's decision or patient's need. However, recently, the effect of H.pylori eradication in development of metachronous gastric cancer was published in NEJM (Choi et al. 2018). Therefore, from now on, H. pylori eradication will be recommended to enrolled patients with H.pylori.

• Study Type: Interventional
• Enrollment (Actual): 580
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • Soonchunhyang University Bucheon Hospital
  • Busan, Korea, Republic of
    • Dongnam Institute of Radiological and Medical Science
  • Jinju, Korea, Republic of
    • Gyeongsang National University
  • Seoul, Korea, Republic of
    • Yonsei Univeristy College of Medicine
  • Suwon, Korea, Republic of
    • Ajou University School of Medicine
  • Chonnam
    • Hwasun, Chonnam, Korea, Republic of
      • Chonnam National University Hwasun Hospital
  • Gyeonggi-do
    • Goyang, Gyeonggi-do, Korea, Republic of
      • National Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• single lesion of adenocarcinoma in preoperative endoscopic biopsy
• clinical stage T1N0 in the preoperative evaluation of endoscopy and computed tomography
• tumor size: less than 3cm
• location: 2cm far from the pylorus or cardia
• aged 20 to 80
• ECOG 0 or 1
• patient who signed the agreement
• patient who is suspected to underwent laparoscopy assisted gastrectomy

Exclusion Criteria:

• indication of endoscopic submucosal resection
• inoperable due to poor cardiac, pulmonary function
• pregnant
• having allergic reaction, previous upper abdominal surgery except laparoscopic cholecystectomy, previous radiation therapy to upper abdomen
• diagnosed as malignancy within 5 years except carcinoma in situ of cervix cancer and thyroid cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laparoscopic Sentinel Node Biopsy; Laparoscopic Sentinel Node Biopsy or Stomach Preserving Surgery could be performed in this arm	Procedure: Laparoscopic Sentinel Node Biopsy; Laparoscopic Sentinel Node Biopsy or Stomach Preserving Surgery could be performed in the experimental arm.
Active Comparator: Laparoscopy Assisted Gastrectomy; Conventional procedure is laparoscopy assisted gastrectomy in early gastric cancer patient.	Procedure: Laparoscopy Assisted Gastrectomy; In the control arm, laparoscopy assisted gastrectomy with lymph node dissection (D1+ or more) will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3 year disease free survival rate	A total of enrollment period is suspected to be four years and patients will be followed up for five years. However, primary end point is 3 year disease free survival and we can analyze survival data at three year later from when the last enrolled patients underwent intervention.	3 years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative morbidity and mortality	We will collect morbidity and mortality data for postoperative 30 days. Therefore, this end point will be completed one month later from when the last enrolled patients underwent intervention.	30 days after surgery
scores of global health status scale, functional scales, and symptom scales/items of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30 and STO22	Survey for quality of life will be performed regularly for three years after surgery. Measurement tool is the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30 and STO22. In EORTC QLQ C30, there are 1 global health status scale, 5 functonal scales, and 9 symptom scales/items. EORTC QLQ STO22 includes 5 symptom scales and 4 single items. Each scale and item ranges 0 to 100. Higher score of global health status and functinoal scales indicate better quality of life and lower score of symptom scales indicates better quality of life. There is no summed score in these questionnaires.	3 years
5 year disease free survival rate	A total of enrollment period is suspected to be four years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention	5 years after surgery
5 year overall survival rate	A total of enrollment period is suspected to be four years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention	5 years after surgery
3 year recurrence free survival rate	A total of enrollment period is suspected to be four years and patients will be followed up for five years. However, primary end point is 3 year disease free survival and we can analyze survival data at three year later from when the last enrolled patients underwent intervention.	3 years after surgery
3 year disease specific death rate	A total of enrollment period is suspected to be four years and patients will be followed up for five years. However, primary end point is 3 year disease free survival and we can analyze survival data at three year later from when the last enrolled patients underwent intervention.	3 years after surgery
3 year overall survival rate	3 years after surgery	3 years after surgery
5 year recurrence free survival rate	A total of enrollment period is suspected to be four years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention.	5 years after surgery
5 year disease specific death rate	A total of enrollment period is suspected to be four years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention	5 years after surgery

Collaborators and Investigators

• Sponsor: National Cancer Center, Korea

Publications and helpful links

General Publications

• Kim YW, Min JS, Yoon HM, An JY, Eom BW, Hur H, Lee YJ, Cho GS, Park YK, Jung MR, Park JH, Hyung WJ, Jeong SH, Kook MC, Han M, Nam BH, Ryu KW. Laparoscopic Sentinel Node Navigation Surgery for Stomach Preservation in Patients With Early Gastric Cancer: A Randomized Clinical Trial. J Clin Oncol. 2022 Jul 20;40(21):2342-2351. doi: 10.1200/JCO.21.02242. Epub 2022 Mar 24.
• An JY, Min JS, Hur H, Lee YJ, Cho GS, Park YK, Jung MR, Park JH, Hyung WJ, Jeong SH, Kim YW, Yoon HM, Eom BW, Kook MC, Han MR, Nam BH, Ryu KW; SEntinel Node ORIented Tailored Approach (SENORITA) Study Group. Laparoscopic sentinel node navigation surgery versus laparoscopic gastrectomy with lymph node dissection for early gastric cancer: short-term outcomes of a multicentre randomized controlled trial (SENORITA). Br J Surg. 2020 Oct;107(11):1429-1439. doi: 10.1002/bjs.11655. Epub 2020 Jun 3.
• Park JY, Kim YW, Ryu KW, Nam BH, Lee YJ, Jeong SH, Park JH, Hur H, Han SU, Min JS, An JY, Hyung WJ, Cho GS, Jeong GA, Jeong O, Park YK, Jung MR, Yoon HM, Eom BW. Assessment of laparoscopic stomach preserving surgery with sentinel basin dissection versus standard gastrectomy with lymphadenectomy in early gastric cancer-A multicenter randomized phase III clinical trial (SENORITA trial) protocol. BMC Cancer. 2016 May 31;16:340. doi: 10.1186/s12885-016-2336-8.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2013
• Primary Completion (Actual): January 15, 2020
• Study Completion (Actual): December 21, 2021

Study Registration Dates

• First Submitted: March 4, 2013
• First Submitted That Met QC Criteria: March 4, 2013
• First Posted (Estimate): March 5, 2013

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 13, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: phase 3; early gastric cancer; laparoscopic sentinel lymph node biopsy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: SENORITA 2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We will discuss this topic in the research meeting later.