Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy

Early Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01804998
• Other study ID #: SENORITA 2013
• Status: Completed
• Phase: N/A
• Start date: March 27, 2013
• Est. completion date: December 21, 2021

Study information

• Verified date: February 2022
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 580
• Est. completion date: December 21, 2021
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Early Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Laparoscopic Sentinel Node Biopsy
Laparoscopic Sentinel Node Biopsy or Stomach Preserving Surgery could be performed in the experimental arm.
• Laparoscopy Assisted Gastrectomy
In the control arm, laparoscopy assisted gastrectomy with lymph node dissection (D1+ or more) will be performed.

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon
Korea, Republic of	Dongnam Institute of Radiological and Medical Science	Busan
Korea, Republic of	National Cancer Center	Goyang	Gyeonggi-do
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun	Chonnam
Korea, Republic of	Gyeongsang National University	Jinju
Korea, Republic of	Yonsei Univeristy College of Medicine	Seoul
Korea, Republic of	Ajou University School of Medicine	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	3 year overall survival rate	3 years after surgery	3 years after surgery
Secondary	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
Secondary	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