Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy
Primary Purpose
Early Gastric Cancer
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Laparoscopic Sentinel Node Biopsy
Laparoscopy Assisted Gastrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Early Gastric Cancer focused on measuring laparoscopic sentinel lymph node biopsy, phase 3, early gastric cancer
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
Sites / Locations
- Chonnam National University Hwasun Hospital
- National Cancer Center
- Soonchunhyang University Bucheon Hospital
- Dongnam Institute of Radiological and Medical Science
- Gyeongsang National University
- Yonsei Univeristy College of Medicine
- Ajou University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Laparoscopic Sentinel Node Biopsy
Laparoscopy Assisted Gastrectomy
Arm Description
Laparoscopic Sentinel Node Biopsy or Stomach Preserving Surgery could be performed in this arm
Conventional procedure is laparoscopy assisted gastrectomy in early gastric cancer patient.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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 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
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 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 year overall survival rate
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 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
Full Information
NCT ID
NCT01804998
First Posted
March 4, 2013
Last Updated
February 13, 2022
Sponsor
National Cancer Center, Korea
1. Study Identification
Unique Protocol Identification Number
NCT01804998
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 27, 2013 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
December 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Gastric Cancer
Keywords
laparoscopic sentinel lymph node biopsy, phase 3, early gastric cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Stomach preserving surgery after laparoscopic sentinel node dissection and evaluation
Masking
None (Open Label)
Allocation
Randomized
Enrollment
580 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic Sentinel Node Biopsy
Arm Type
Experimental
Arm Description
Laparoscopic Sentinel Node Biopsy or Stomach Preserving Surgery could be performed in this arm
Arm Title
Laparoscopy Assisted Gastrectomy
Arm Type
Active Comparator
Arm Description
Conventional procedure is laparoscopy assisted gastrectomy in early gastric cancer patient.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Sentinel Node Biopsy
Intervention Description
Laparoscopic Sentinel Node Biopsy or Stomach Preserving Surgery could be performed in the experimental arm.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopy Assisted Gastrectomy
Intervention Description
In the control arm, laparoscopy assisted gastrectomy with lymph node dissection (D1+ or more) will be performed.
Primary Outcome Measure Information:
Title
3 year disease free survival rate
Description
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.
Time Frame
3 years after surgery
Secondary Outcome Measure Information:
Title
postoperative morbidity and mortality
Description
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.
Time Frame
30 days after surgery
Title
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
Description
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.
Time Frame
3 years
Title
5 year disease free survival rate
Description
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
Time Frame
5 years after surgery
Title
5 year overall survival rate
Description
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
Time Frame
5 years after surgery
Title
3 year recurrence free survival rate
Description
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.
Time Frame
3 years after surgery
Title
3 year disease specific death rate
Description
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.
Time Frame
3 years after surgery
Title
3 year overall survival rate
Description
3 years after surgery
Time Frame
3 years after surgery
Title
5 year recurrence free survival rate
Description
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.
Time Frame
5 years after surgery
Title
5 year disease specific death rate
Description
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
Time Frame
5 years after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
State/Province
Chonnam
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Soonchunhyang University Bucheon Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
Dongnam Institute of Radiological and Medical Science
City
Busan
Country
Korea, Republic of
Facility Name
Gyeongsang National University
City
Jinju
Country
Korea, Republic of
Facility Name
Yonsei Univeristy College of Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University School of Medicine
City
Suwon
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
We will discuss this topic in the research meeting later.
Citations:
PubMed Identifier
35324317
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.
Results Reference
derived
PubMed Identifier
32492186
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.
Results Reference
derived
PubMed Identifier
27246120
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.
Results Reference
derived
Learn more about this trial
Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy
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