Early Gastric CancerNCT05978882
Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Using Fluorescence (SENORITA4)
A study testing Laparoscopic sentinel navigation surgery using fluorescence in people with Early Gastric Cancer, run by National Cancer Center, Korea at 7 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Early Gastric Cancer
- What is being tested?
- Laparoscopic sentinel navigation surgery using fluorescence
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 17 Aug 2023to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
South Korea7 sites
Dongnam Inst. of Radiological & Medical Science
Busan, Gijang-gun, 46033
Gyeongsang National University Changwon Hospital
Changwon, 51472
Ajou University Medical Center
Gyeonggi-do, Suwon-si, 16499
Gyeongsang National University Hospital
Gyeongsang, Gingu-si, 52727
Sevrance Hospital
Seoul, Sinchon, 03722
Samsung Medical Center
Seoul
Ji Yeong An, jar319.an@samsung.com
Soon Chun Hyang University Hospital Bucheon
Seoul
In Jo
About this study
Official title: Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Using Fluorescence (SENORITA4 Trial)
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.
Read the 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.
- Conditions
- Early Gastric Cancer
- Being tested
- Laparoscopic sentinel navigation surgery using fluorescence
- Keywords
- Early gastric cancer, Sentinel lymph node, Fluorescence, Stomach-preserving surgery, Quality of life
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic sentinel navigation surgery using fluorescenceProcedure or surgery
If the frozen biopsy of sentinel lymph nodes are all negative using fluorescence, stomach-preserving surgery is performed
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic sentinel navigation surgery | Experimental | compare the detection rate of sentinel lymph nodes to that of previous study (SENORITA1 trial) Receives: Procedure: Laparoscopic sentinel navigation surgery using fluorescence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of Sentinel lymph nodes
number of patients whose sentinel nodes are detected / enrolled number of patients *100
Measured: 15 days after operation
Secondary outcomes (9)
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.
Measured: 3 year after surgery
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.
Measured: 3 year after surgery
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.
Measured: 3 year after surgery
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.
Measured: 3 year 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 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.
Measured: 5 years
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
Measured: 5 years
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
Measured: 5 years
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
Measured: 5 years
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start17 Aug 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 203 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- 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
- Responsible party
- Principal investigator, Hong Man Yoon, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978882
- Sponsor's protocol ID
- NCC2023-0145
- Status last verified
- Jul 2023
- First submitted
- 20 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Using Fluorescence (SENORITA4 Trial)
- ClinicalTrials.gov ID
- NCT05978882
- Acronym / sponsor ID
- NCC2023-0145
- Conditions
- Early Gastric Cancer
- Keywords
- Early gastric cancer, Sentinel lymph node, Fluorescence, Stomach-preserving surgery, Quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 203 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- 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
- Study start
- 17 Aug 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic sentinel navigation surgery | Experimental | Procedure: Laparoscopic sentinel navigation surgery using fluorescencecompare the detection rate of sentinel lymph nodes to that of previous study (SENORITA1 trial) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic sentinel navigation surgery using fluorescenceIf the frozen biopsy of sentinel lymph nodes are all negative using fluorescence, stomach-preserving surgery is performed | Procedure or surgery | Laparoscopic sentinel navigation surgery |
Primary outcome
Detection rate of Sentinel lymph nodes
Time frame: 15 days after operation
number of patients whose sentinel nodes are detected / enrolled number of patients *100
9 secondary outcomes
3 year disease free survival
Time frame: 3 year after surgery
3 year overall survival rate
Time frame: 3 year after surgery
3 year disease specific death rate
Time frame: 3 year after surgery
3 year recurrence free survival rate
Time frame: 3 year 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
Time frame: 5 years
5 year disease free survival rate
Time frame: 5 years
5 year overall survival rate
Time frame: 5 years
5 year disease specific death rate
Time frame: 5 years
5 year recurrence free survival rate
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic sentinel navigation surgery using fluorescence in people with Early Gastric Cancer, run by National Cancer Center, Korea at 7 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong Man Yoon, MD (+82-31-920-1710, red10000@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of Sentinel lymph nodes (time frame: 15 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.