Clinical trial NCT01804998: Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy
Official title: Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy and Stomach Preserving Surgery in Early Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Gastric Cancer
Keywords: laparoscopic sentinel lymph node biopsy
phase 3
early gastric cancer
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2013-03-05
Enrollment: 580
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stomach preserving surgery after laparoscopic sentinel node dissection and evaluation
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 3 year disease free survival rate
timeFrame: 3 years after surgery
Secondary outcomes:
measure: postoperative morbidity and mortality
timeFrame: 30 days after surgery
measure: 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
timeFrame: 3 years
measure: 5 year disease free survival rate
timeFrame: 5 years after surgery
measure: 5 year overall survival rate
timeFrame: 5 years after surgery
measure: 3 year recurrence free survival rate
timeFrame: 3 years after surgery
measure: 3 year disease specific death rate
timeFrame: 3 years after surgery
measure: 3 year overall survival rate
timeFrame: 3 years after surgery
measure: 5 year recurrence free survival rate
timeFrame: 5 years after surgery
measure: 5 year disease specific death rate
timeFrame: 5 years after surgery
Other outcomes:
Locations:
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Chonnam
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
city: Busan
country: Korea, Republic of
facility: Dongnam Institute of Radiological and Medical Science
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University
city: Seoul
country: Korea, Republic of
facility: Yonsei Univeristy College of Medicine
city: Suwon
country: Korea, Republic of
facility: Ajou University School of Medicine
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.