Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Early Gastric Cancer

Intervention / Treatment
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* Procedure: Laparoscopic Sentinel Node Biopsy
* Procedure: Laparoscopy Assisted Gastrectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Stomach preserving surgery after laparoscopic sentinel node dissection and evaluation
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic sentinel lymph node biopsy, phase 3, early gastric cancer