Back to resultsFeasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Using Fluorescence (SENORITA4)
Primary Purpose
Early Gastric Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Laparoscopic sentinel navigation surgery using fluorescence
Sponsored by
About this trial
This is an interventional treatment trial for Early Gastric Cancer focused on measuring Early gastric cancer, Sentinel lymph node, Fluorescence, Stomach-preserving surgery, Quality of life
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 laparoscopic or robotic gastrectomy Exclusion Criteria: indication of endoscopic submucosal resection inoperable due to poor cardiac, and 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
- Dongnam Inst. of Radiological & Medical Science
- Gyeongsang National University Hospital
- Sevrance Hospital
- Ajou University Medical Center
- Gyeongsang National University Changwon Hospital
- Samsung Medical Center
- Soon Chun Hyang University Hospital Bucheon
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Laparoscopic sentinel navigation surgery
Arm Description
compare the detection rate of sentinel lymph nodes to that of previous study (SENORITA1 trial)
Outcomes
Primary Outcome Measures
Detection rate of Sentinel lymph nodes
number of patients whose sentinel nodes are detected / enrolled number of patients *100
Secondary Outcome Measures
3 year disease free survival
A total of enrollment period is suspected to be three years and patients will be followed up for five years.
3 year overall survival rate
A total of enrollment period is suspected to be three years and patients will be followed up for five years.
3 year disease specific death rate
A total of enrollment period is suspected to be three years and patients will be followed up for five years.
3 year recurrence free survival rate
A total of enrollment period is suspected to be three years and patients will be followed up for five years.
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 functional 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 three 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 three 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 three 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 recurrence free survival rate
A total of enrollment period is suspected to be three 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
NCT05978882
First Posted
July 20, 2023
Last Updated
July 31, 2023
Sponsor
National Cancer Center, Korea
Collaborators
Ajou University School of Medicine, Chonnam National University Hospital, Dongnam Institute of Radiological & Medical Sciences, Gyeongsang National University Hospital, Gyeongsang National University Changwon Hospital, Samsung Medical Center, Severance Hospital, Soon Chun Hyang University
1. Study Identification
Unique Protocol Identification Number
NCT05978882
Brief Title
Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Using Fluorescence (SENORITA4)
Official Title
Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Using Fluorescence (SENORITA4 Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 17, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea
Collaborators
Ajou University School of Medicine, Chonnam National University Hospital, Dongnam Institute of Radiological & Medical Sciences, Gyeongsang National University Hospital, Gyeongsang National University Changwon Hospital, Samsung Medical Center, Severance Hospital, Soon Chun Hyang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
SENORITA 1 trial showed laparoscopic sentinel lymph node biopsy and stomach preserving surgery in early gastric cancer can increase the quality of life. (Ryu KW et al. JCO 2022) The radioactive isotope is difficult to use because of the hazard of radiation and shortage of materials. The aim of this study is to investigate whether laparoscopic sentinel lymph node biopsy and stomach-preserving surgery using only fluorescence is feasible.
Detailed Description
Injection of Indocyanine Green (ICG)
Endoscopic injection of 0.25mg/ml of ICG on 4 sites around gastric cancer
Identification of sentinel basin using fluorescence laparoscopy
Laparoscopic sentinel basin dissection and identification of sentinel node at the back table
Surgical considerations
Conventional gastrectomy is performed if positive sentinel nodes are diagnosed in the frozen section.
If micrometastasis or isolated tumor cells in sentinel basin lymph nodes were diagnosed in permanent pathology, re-operation of conventional gastrectomy is not performed.
However, re-operation of conventional gastrectomy should be performed in case of macrometastasis, deep and lateral margin positive, more than pT2 lesion in the permanent pathology.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Gastric Cancer
Keywords
Early gastric cancer, Sentinel lymph node, Fluorescence, Stomach-preserving surgery, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
203 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic sentinel navigation surgery
Arm Type
Experimental
Arm Description
compare the detection rate of sentinel lymph nodes to that of previous study (SENORITA1 trial)
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic sentinel navigation surgery using fluorescence
Intervention Description
If the frozen biopsy of sentinel lymph nodes are all negative using fluorescence, stomach-preserving surgery is performed
Primary Outcome Measure Information:
Title
Detection rate of Sentinel lymph nodes
Description
number of patients whose sentinel nodes are detected / enrolled number of patients *100
Time Frame
15 days after operation
Secondary Outcome Measure Information:
Title
3 year disease free survival
Description
A total of enrollment period is suspected to be three years and patients will be followed up for five years.
Time Frame
3 year after surgery
Title
3 year overall survival rate
Description
A total of enrollment period is suspected to be three years and patients will be followed up for five years.
Time Frame
3 year after surgery
Title
3 year disease specific death rate
Description
A total of enrollment period is suspected to be three years and patients will be followed up for five years.
Time Frame
3 year after surgery
Title
3 year recurrence free survival rate
Description
A total of enrollment period is suspected to be three years and patients will be followed up for five years.
Time Frame
3 year 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 functional 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
5 years
Title
5 year disease free survival rate
Description
A total of enrollment period is suspected to be three 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
Title
5 year overall survival rate
Description
A total of enrollment period is suspected to be three 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
Title
5 year disease specific death rate
Description
A total of enrollment period is suspected to be three 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
Title
5 year recurrence free survival rate
Description
A total of enrollment period is suspected to be three 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
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 laparoscopic or robotic gastrectomy
Exclusion Criteria:
indication of endoscopic submucosal resection
inoperable due to poor cardiac, and 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Man Yoon, MD
Phone
+82-31-920-1710
Email
red10000@ncc.re.kr
Facility Information:
Facility Name
Dongnam Inst. of Radiological & Medical Science
City
Busan
State/Province
Gijang-gun
ZIP/Postal Code
46033
Country
Korea, Republic of
Facility Name
Gyeongsang National University Hospital
City
Gyeongsang
State/Province
Gingu-si
ZIP/Postal Code
52727
Country
Korea, Republic of
Facility Name
Sevrance Hospital
City
Seoul
State/Province
Sinchon
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Ajou University Medical Center
City
Gyeonggi-do
State/Province
Suwon-si
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Gyeongsang National University Changwon Hospital
City
Changwon
ZIP/Postal Code
51472
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Yeong An
Email
jar319.an@samsung.com
Facility Name
Soon Chun Hyang University Hospital Bucheon
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
In Jo
12. IPD Sharing Statement
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Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Using Fluorescence (SENORITA4)
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