Gastric CancerNCT03385018
Trial for Application of Laparoscopic Total Gastrectomy With Lymph Node Dissection for Gastric Cancer (KLASS-06)
A study testing Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approach and Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approach in people with Gastric Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Although Laparoscopic gastrectomy for both early and locally advanced gastric cancer has gained popularity, the use of laparoscopic total gastrectomy for proximal advanced gastric cancer is still limited to some experienced surgeons, because of its technical difficulties in D2 lymph node dissection and anastomoses. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approach and Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 772 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Apr 2018to 31 Dec 2027
- 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
- Patients who are over 20 and below 80 years old
- Patients who have performance status of ECOG 0 or 1
- Patients with American Society of Anesthesiology score of class I to III
- Patients who are diagnosed with gastric adenocarcinoma not involving Z-line by endoscopy with biopsy
- Patients with tumors which can be curatively resected by total gastrectomy with lymph node dissection based on preoperative study
- Patients who have primary gastric carcinoma invaded into over muscle propria, and not into adjacent organ in preoperative studies (cT2 ~ cT4a)
Show all 9Show fewer
- Patients who have no metastasis to lymph nodes or limited metastasis to perigastric lymph node metastasis in preoperative studies (cN0 ~ cN2)
- Patients who agree with participating in the clinical study with informed consents
- Patients who can be followed for at least 3 years after study enrollment
Who cannot join
- Patients who have possibility of distant metastasis in preoperative studies
- Patients who have history of gastric resection with any cause
- Patients who have complications (bleeding or obstruction) of gastric cancer
- Patients who are treated by chemo(radio)therapy or endoscopic submucosal dissection for gastric cancer
- Patients who are diagnosed and treated with other malignancies within 5 years
- Vulnerable patients
- Patients who participating or participated in other clinical trial within 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Department of Surgery, Yonsei University College of Medicine, Seoul, Korea
Seoul, 120-752
Woo Jin Hyung, MD, +82-2-2228-2100, WJHYUNG@yuhs.ac
About this study
Official title: Multicenter Randomized Controlled Trial for Application of Laparoscopic Total Gastrectomy With Lymph Node Dissection for Gastric Cancer (KLASS-06)
Although Laparoscopic gastrectomy for both early and locally advanced gastric cancer has gained popularity, the use of laparoscopic total gastrectomy for proximal advanced gastric cancer is still limited to some experienced surgeons, because of its technical difficulties in D2 lymph node dissection and anastomoses.
Some retrospective and cohort studies regarding laparoscopic total gastrectomy with lymph node dissection suggested the likelihood of application of laparoscopic surgery for proximal gastric cancer. However, there has been no randomized clinical trial comparing results of laparoscopic total gastrectomy with D2 lymph node dissection with open conventional surgery.
Therefore, we aimed to verify the efficacy of laparoscopic total gastrectomy with D2(D2-10) lymph node dissection, technical and oncologic safety compared with open surgery via multicenter randomized clinical trial.
- Conditions
- Gastric Cancer
- Being tested
- Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approach, Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approach
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approachProcedure or surgery
- Total gastrectomy with D2(D2-10) lymph node dissection by laparoscopic approach
- The number of trocars is 6 or less
- Roux-en-Y esophagojejunostomy with any stapling method
- Enough(negative) margin from tumor
- LN station #1, 2, 3, 4d, 4sb, 5, 6, 7, 8a, 9, (10), 11p, 11d, 12a should be examined
- Washing cytology
- Frozen biopsy for surgical margin at surgeons discretion
- Complete omentectomy for grossly serosa-involved tumor
- Combined organ resection only in cholecystectomy and splenectomy
- Indwelling nasogastric tube and drainage catheter at surgeons discretion
- D2 lymphadenectomy should be performed : dissection of LN stations No.4d, 4sb, 4sa, 2, 10 (splenic hilar LN can be left according to the clinical stage), 6, 5, 12a, 8a, 9, 7, 1, 3, 11p, 11d with prevention of pancreatic injury during suprapancreatic dissection
Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approachProcedure or surgery
- Total gastrectomy with D2(D2-10) lymph node dissection by open conventional approach
- Roux-en-Y esophagojejunostomy with any stapling method
- Enough(negative) margin from tumor
- LN station #1, 2, 3, 4d, 4sb, 5, 6, 7, 8a, 9, (10), 11p, 11d, 12a should be examined
- Washing cytology
- Frozen biopsy for surgical margin at surgeons discretion
- Complete omentectomy for grossly serosa-involved tumor
- Indwelling nasogastric tube and drainage catheter at surgeons discretion
- D2 lymphadenectomy should be performed : dissection of LN stations No.4d, 4sb, 4sa, 2, 10 (splenic hilar LN can be left according to the clinical stage), 6, 5, 12a, 8a, 9, 7, 1, 3, 11p, 11d with prevention of pancreatic injury during suprapancreatic dissection
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic group | Experimental | Arm Description: Laparoscopic radical total gastrectomy with D2 (or D2-#10) lymph node dissection Receives: Procedure: Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approach |
| Open group | Active comparator | Open radical total gastrectomy with D2 (or D2-#10) lymph node dissection Receives: Procedure: Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 year relapse-free survival
Non-inferiority of 3 year relapse-free survival rate after laparoscopic radical total gastrectomy and lymphadenectomy for locally advanced gastric cancer comparing with open conventional surgery.
The "event" of relapse-free survival is defined as "recurrence" after 4 weeks of operation.
The "censoring" is defined as non-traceable patient who cannot be confirmed with recurrence or patient who are alive without recurrence until follow-up.
The "relapse-free survival time" is defined as the time from surgery to "event" or "censoring".
Measured: 3 years after surgery
Secondary outcomes (12)
3 year overall survival rate
Measured: 3 years after surgery
5 year relapse-free and overall survival
Measured: 5 years after surgery
Morbidity (early period)
Measured: from Operation day until POD 21
Morbidity (late period)
Measured: from POD (Post-Operative Day) 22 until 5 years after surgery
Mortality
death with any cause
Measured: at POD 30
Mortality
death with any cause
Measured: at POD 90
Quality of life(EORTC QLQ-C30)
Quality of life measured by EORTC QLQ-C30(Version 3) The questionnaire was designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of 5 multiitem scales (physical, role, social, emotional and cognitive functioning) and 9 single items (pain, fatigue, financial impact, appetite loss, nausea/vomiting, diarrhea, constipation, sleep disturbance and quality of life).
Measured: at POD 21
Quality of life(EORTC QLC STO22)
Quality of life measured by EORTC QLC STO22. The EORTC QLQ-STO 22 module contains 22 items in a similar layout and response format to the EORTC QLQ-C30. The hypothesised scale structure of the module consists of five scales (dysphagia, eating restrictions, pain, reflux and anxiety) and three single items (dry mouth, body image and hair loss).
Measured: at POD 21
Quality of life(EORTC QLQ-C30)
Quality of life measured by EORTC QLQ-C30(Version 3)
Measured: 3 months after surgery
Quality of life(EORTC QLC STO22)
Quality of life measured by EORTC QLC STO22. The EORTC QLQ-STO 22 module contains 22 items in a similar layout and response format to the EORTC QLQ-C30. The hypothesised scale structure of the module consists of five scales (dysphagia, eating restrictions, pain, reflux and anxiety) and three single items (dry mouth, body image and hair loss).
Measured: 3 months after surgery
Quality of life(EORTC QLQ-C30)
Quality of life measured by EORTC QLQ-C30(Version 3)
Measured: 12 months after surgery
Quality of life(EORTC QLC STO22)
Quality of life measured by EORTC QLC STO22. The EORTC QLQ-STO 22 module contains 22 items in a similar layout and response format to the EORTC QLQ-C30. The hypothesised scale structure of the module consists of five scales (dysphagia, eating restrictions, pain, reflux and anxiety) and three single items (dry mouth, body image and hair loss).
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start5 Apr 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm randomized controlled study
- Masking
- None (open label)
- Enrolment
- 772 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385018
- Sponsor's protocol ID
- 4-2017-0940
- Status last verified
- Mar 2019
- First submitted
- 20 Dec 2017
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Trial for Application of Laparoscopic Total Gastrectomy With Lymph Node Dissection for Gastric Cancer (KLASS-06)
- ClinicalTrials.gov ID
- NCT03385018
- Acronym / sponsor ID
- 4-2017-0940
- Conditions
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 772 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Dec 2017 (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.
Although Laparoscopic gastrectomy for both early and locally advanced gastric cancer has gained popularity, the use of laparoscopic total gastrectomy for proximal advanced gastric cancer is still limited to some experienced surgeons, because of its technical difficulties in D2 lymph node dissection and anastomoses.
Some retrospective and cohort studies regarding laparoscopic total gastrectomy with lymph node dissection suggested the likelihood of application of laparoscopic surgery for proximal gastric cancer. However, there has been no randomized clinical trial comparing results of laparoscopic total gastrectomy with D2 lymph node dissection with open conventional surgery.
Therefore, we aimed to verify the efficacy of laparoscopic total gastrectomy with D2(D2-10) lymph node dissection, technical and oncologic safety compared with open surgery via multicenter randomized clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2-arm randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic group | Experimental | Procedure: Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approachArm Description: Laparoscopic radical total gastrectomy with D2 (or D2-#10) lymph node dissection |
| Open group | Active comparator | Procedure: Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approachOpen radical total gastrectomy with D2 (or D2-#10) lymph node dissection |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who are over 20 and below 80 years old
- Patients who have performance status of ECOG 0 or 1
- Patients with American Society of Anesthesiology score of class I to III
- Patients who are diagnosed with gastric adenocarcinoma not involving Z-line by endoscopy with biopsy
- Patients with tumors which can be curatively resected by total gastrectomy with lymph node dissection based on preoperative study
Key exclusion criteria (7 listed)
- Patients who have possibility of distant metastasis in preoperative studies
- Patients who have history of gastric resection with any cause
- Patients who have complications (bleeding or obstruction) of gastric cancer
- Patients who are treated by chemo(radio)therapy or endoscopic submucosal dissection for gastric cancer
- Patients who are diagnosed and treated with other malignancies within 5 years
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 |
|---|---|---|
| Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approach* Total gastrectomy with D2(D2-10) lymph node dissection by laparoscopic approach * The number of trocars is 6 or less * Roux-en-Y esophagojejunostomy with any stapling method * Enough(negative) margin from tumor * LN station #1, 2, 3, 4d, 4sb, 5, 6, 7, 8a, 9, (10), 11p, 11d, 12a should be examined * Washing cytology * Frozen biopsy for surgical margin at surgeons discretion * Complete omentectomy for grossly serosa-involved tumor * Combined organ resection only in cholecystectomy and splenectomy * Indwelling nasogastric tube and drainage catheter at surgeons discretion * D2 lymphadenectomy should be performed : dissection of LN stations No.4d, 4sb, 4sa, 2, 10 (splenic hilar LN can be left according to the clinical stage), 6, 5, 12a, 8a, 9, 7, 1, 3, 11p, 11d with prevention of pancreatic injury during suprapancreatic dissection | Procedure or surgery | Laparoscopic group |
| Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approach* Total gastrectomy with D2(D2-10) lymph node dissection by open conventional approach * Roux-en-Y esophagojejunostomy with any stapling method * Enough(negative) margin from tumor * LN station #1, 2, 3, 4d, 4sb, 5, 6, 7, 8a, 9, (10), 11p, 11d, 12a should be examined * Washing cytology * Frozen biopsy for surgical margin at surgeons discretion * Complete omentectomy for grossly serosa-involved tumor * Indwelling nasogastric tube and drainage catheter at surgeons discretion * D2 lymphadenectomy should be performed : dissection of LN stations No.4d, 4sb, 4sa, 2, 10 (splenic hilar LN can be left according to the clinical stage), 6, 5, 12a, 8a, 9, 7, 1, 3, 11p, 11d with prevention of pancreatic injury during suprapancreatic dissection | Procedure or surgery | Open group |
Primary outcome
3 year relapse-free survival
Time frame: 3 years after surgery
Non-inferiority of 3 year relapse-free survival rate after laparoscopic radical total gastrectomy and lymphadenectomy for locally advanced gastric cancer comparing with open conventional surgery. The "event" of relapse-free survival is defined as "recurrence" after 4 weeks of operation. The "censoring" is defined as non-traceable patient who cannot be confirmed with recurrence or patient who are alive without recurrence until follow-up. The "relapse-free survival time" is defined as the time from surgery to "event" or "censoring".
12 secondary outcomes
3 year overall survival rate
Time frame: 3 years after surgery
5 year relapse-free and overall survival
Time frame: 5 years after surgery
Morbidity (early period)
Time frame: from Operation day until POD 21
Morbidity (late period)
Time frame: from POD (Post-Operative Day) 22 until 5 years after surgery
Mortality
Time frame: at POD 30
Mortality
Time frame: at POD 90
Quality of life(EORTC QLQ-C30)
Time frame: at POD 21
Quality of life(EORTC QLC STO22)
Time frame: at POD 21
Quality of life(EORTC QLQ-C30)
Time frame: 3 months after surgery
Quality of life(EORTC QLC STO22)
Time frame: 3 months after surgery
Quality of life(EORTC QLQ-C30)
Time frame: 12 months after surgery
Quality of life(EORTC QLC STO22)
Time frame: 12 months after surgery
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 19 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Gastric Cancer
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
Not yet recruitingPhase 2
Serplulimab, DOS and Lenvatinib Combine With PIPAC in the Oligometastatic Peritoneal Metastasis of Gastric/Gastroesophageal Junction Adenocarcinoma
Gastric/Gastroesophageal Junction Adenocarcinoma, Oligometastatic Peritoneal Metastasis
Not yet recruitingPhase 2
Application of Intraperitoneal Hyperthermic Chemotherapy in the Treatment of Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (Diagnosis)
Not yet recruitingObservational study
Lymph Node Dissection After Neoadjuvant Therapy for Gastric and EGJ Adenocarcinoma
Gastric Adenocarcinoma, Esophagogastric Junction Adenocarcinoma
RecruitingPhase 2
Non-covalent BTK Inhibitor Nemtabrutinib in Combination With the CD20 Monoclonal Antibody Rituximab for the Treatment of Marginal Zone Lymphoma
Conjunctival Mucosa-Associated Lymphoid Tissue Lymphoma, Gastric Mucosa-Associated Lymphoid Tissue Lymphoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approach and Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approach in people with Gastric Cancer, run by Yonsei University at 1 site 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 9 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Woo Jin Hyung, MD, PhD (+82-2-2228-2100, wjhyung@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 year relapse-free survival (time frame: 3 years after surgery). 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 19 Mar 2019.