Gastric CancerPhase 2NCC181NCT01163812
Clinical Trial for Laparoscopic D2 Gastrectomy
A Phase 2 study testing Laparoscopic D2 distal gastrectomy in people with Gastric Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
Objectives of this study was to determine whether laparoscopy-assisted distal gastrectomy (LADG) with complete D2 lymph node dissection for gastric cancer is a safe and effective surgical option. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Laparoscopic D2 distal gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2006to Oct 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the stomach,
- Age between 18 and 75 years, performance status of ECOG 0-1
- Signed informed consent
- Location of the primary tumor in the antrum, angle and lower body
- No evidence of distant metastasis or invasion to adjacent organs or serosal infiltration,
- Enlarged lymph node size 2 cm or less on CT and no conglomerate nodes or regional
- Lymph node metastasis confined to perigastric nodes (N1) as shown on by CT and EUS
Who cannot join
- Metastatic disease, previous history of malignancy in any organ, any co-morbidity
- Obviating major surgery, contraindication to laparoscopy such as severe cardiac disease
- Abdominal wall hernias, diaphragmatic hernias, uncorrected coagulopathies, portal hypertension, pregnancy, previous upper abdominal surgery, complicated cases requiring emergency surgery, and an accompanying surgical condition requiring surgery at the same time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase-II Clinical Trial of Laparoscopy-Assisted Distal Gastrectomy With D2 Lymph Node Dissection for Gastric Cancer
Objectives of this study was to determine whether laparoscopy-assisted distal gastrectomy (LADG) with complete D2 lymph node dissection for gastric cancer is a safe and effective surgical option.
Methods: total 64 patients, who are diagnosed preoperatively as having T1-2, N0-1 or M0 gastric cancer, will be prospectively enrolled to undergo LADG with D2 lymph node dissection; two surgeons with experience of over 50 cases of laparoscopic gastrectomy performed the procedures. The compliance rate, defined as cases with no more than one missing lymph node station according to the Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping, for the open gastrectomy with D2 lymph node dissection was 66.0% in a pilot study and was used for calculations of sample size. Compliance rate and other surgical outcomes, including the number of retrieved lymph nodes from each lymph node station, morbidities, mortalities and conversion rate will be analyzed.
Read the detailed description
Gastric cancer is the most common cancer in Korea; the overall age-standardized incidence rates of gastric cancer in Korea have been reported to be 69.6 per 100,000 among males and 26.8 per 100,000 among females in 2000.
Treatment modalities for resectable gastric cancer include endoscopic mucosal resection (EMR), laparoscopy-assisted gastrectomy (LAG) and conventional open gastrectomy. Laparoscopic cancer surgery has been reported to be an acceptable alternative to open surgery in patients with colorectal cancer. However, in gastric cancer, laparoscopic surgery has not yet been validated and, thus, is performed only in a limited number of patients with early gastric cancer; this is due to the technical difficulty in systematic lymph node dissection. For the treatment of advanced gastric cancer (AGC), in countries including Korea and Japan, gastrectomy with D2 lymph node dissection has been the standard operation. With the recent progress in diagnostic techniques, accumulation of experience with laparoscopy-assisted distal gastrectomy (LADG) for early gastric cancer and the increasing interest in a better quality of life, there has been an effort to apply minimally invasive techniques to the treatment of AGC. However, there has been no clinical trial to test the oncological feasibility of LADG with D2 lymph node dissection. There is only one phase-II study that evaluated whether the morbidity associated with LADG was higher than that of open gastrectomy.
Before the indications for LADG can be extended to include patients with advanced cancer, the status of surgical expertise for complete D2 lymph node dissection requires investigation using a prospective clinical study design. If this approach is shown to be feasible, a randomized prospective clinical trial, to compare survival and other surgical outcomes, would be the next step in validating this technique for this group of patients.
This study is to be performed according to the Helsinki Declaration. The study was approved by the Ethics Subcommittee at the National Cancer Center for Research Involving Human Subjects (no. NCCCTS-2005181). All patients will be provided written informed consent before entering the study.
Sample size The sample size was based on the alpha error at 0.05 and 90% of power and the accepted margin of the difference in the compliance rate at 10% based on a non-inferiority test. The target was chosen from the primary end point of the study. For the patients who underwent LADG with D2 lymph node dissection, the compliance rate-defined as cases in which there was no more than one missing lymph node station according to the guidelines of "The Japanese Research Society for Gastric Cancer" (JRSGC) lymph node grouping,11,12-was set up to 55%; for the patients with open distal gastrectomy with D2 lymph node dissection, it was 66%, based on a pilot study. We performed a pilot study to determine the compliance rate in 100 cases of open distal gastrectomy with D2 lymph node dissection before enrollment started. When the data was used for the formula, the total sample size required was determined to be 60 patients. When we added 10% for expected follow-up loss, the total sample size was calculated to be 66 patients.
- Conditions
- Gastric Cancer
- Being tested
- Laparoscopic D2 distal gastrectomy
- Keywords
- D2 lymph node dissection
- 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 D2 distal gastrectomyProcedure or surgery
Also called LADG
Under general endotracheal anesthesia, Five or six ports are used. Lymph node dissection and ligation of vessels are carried out in the laparoscopic field. A partial omentectomy encompassing perigastric nodes is performed laparoscopically. D2 lymphadenectomy is carried out according to the guidelines of the "The Japanese Research Society for Gastric Cancer" for the corresponding location of the primary tumor. A 5- to 6-cm small incision is made transversely in RUQ of the abdomen. Through the incisional window, the stomach is removed from the abdominal cavity and resected. A Billroth-I gastroduodenostomy using an EEA stapler and GIA or a Billroth-II gastrojejunostomy with a hand-sewing technique is performed. The abdomen is then closed after hemostasis is achieved.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic D2 gastrectomy | Experimental | Not described Receives: Procedure: Laparoscopic D2 distal gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance of lymph node dissection
noncompliance : if two or more nodal station is vacant, it is a noncompliant D2 gastrectomy.
Measured: immediate postoperative 1 week
Secondary outcomes (9)
Proportion of patients with retrieved lymph nodes less than 26
Measured: Postoperative 1 week
operative complications
intra, and postopertive complications related to operation.
Measured: Postoperative 1 month
operative time
Measured: postoperative 1 day
estimated blood loss
blood loss during operation.
Measured: postoperative 1 day
amount of administered analgesics
Measured: Postoperative 1 week
time to diet
Measured: postoperative 1 week
time to return of bowel movement
Measured: postoperative 1 week
hospital stay
Measured: postoperative 1 week
distance to resection margin and number of harvested lymph nodes
Measured: postoperative 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startApr 2006
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Investigators
- Young-Woo Kim, MD, PhD, Principal investigator, NCC Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163812
- Sponsor's protocol ID
- NCCCTS-2005181
- Acronym
- NCC181
- Status last verified
- Jul 2010
- First submitted
- 15 Jul 2010
- Last updated
- 19 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ryu KW, Kim YW, Lee JH, Nam BH, Kook MC, Choi IJ, Bae JM. Surgical complications and the risk factors of laparoscopy-assisted distal gastrectomy in early gastric cancer. Ann Surg Oncol. 2008 Jun;15(6):1625-31. doi: 10.1245/s10434-008-9845-x. Epub 2008 Mar 14.
PubMed 18340493Lee JH, Kim YW, Ryu KW, Lee JR, Kim CG, Choi IJ, Kook MC, Nam BH, Bae JM. A phase-II clinical trial of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for gastric cancer patients. Ann Surg Oncol. 2007 Nov;14(11):3148-53. doi: 10.1245/s10434-007-9446-0. Epub 2007 Aug 20.
PubMed 17705092Lee SE, Kim YW, Lee JH, Ryu KW, Cho SJ, Lee JY, Kim CG, Choi IJ, Kook MC, Nam BH, Park SR, Kim MJ, Lee JS. Developing an institutional protocol guideline for laparoscopy-assisted distal gastrectomy. Ann Surg Oncol. 2009 Aug;16(8):2231-6. doi: 10.1245/s10434-009-0490-9. Epub 2009 May 9.
PubMed 19430842
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-II Clinical Trial of Laparoscopy-Assisted Distal Gastrectomy With D2 Lymph Node Dissection for Gastric Cancer
- ClinicalTrials.gov ID
- NCT01163812
- Acronym / sponsor ID
- NCC181 / NCCCTS-2005181
- Conditions
- Gastric Cancer
- Keywords
- D2 lymph node dissection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Apr 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 16 Jul 2010 (estimated)
- 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.
Objectives of this study was to determine whether laparoscopy-assisted distal gastrectomy (LADG) with complete D2 lymph node dissection for gastric cancer is a safe and effective surgical option.
Methods: total 64 patients, who are diagnosed preoperatively as having T1-2, N0-1 or M0 gastric cancer, will be prospectively enrolled to undergo LADG with D2 lymph node dissection; two surgeons with experience of over 50 cases of laparoscopic gastrectomy performed the procedures. The compliance rate, defined as cases with no more than one missing lymph node station according to the Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping, for the open gastrectomy with D2 lymph node dissection was 66.0% in a pilot study and was used for calculations of sample size. Compliance rate and other surgical outcomes, including the number of retrieved lymph nodes from each lymph node station, morbidities, mortalities and conversion rate will be analyzed.
Detailed description
Gastric cancer is the most common cancer in Korea; the overall age-standardized incidence rates of gastric cancer in Korea have been reported to be 69.6 per 100,000 among males and 26.8 per 100,000 among females in 2000.
Treatment modalities for resectable gastric cancer include endoscopic mucosal resection (EMR), laparoscopy-assisted gastrectomy (LAG) and conventional open gastrectomy. Laparoscopic cancer surgery has been reported to be an acceptable alternative to open surgery in patients with colorectal cancer. However, in gastric cancer, laparoscopic surgery has not yet been validated and, thus, is performed only in a limited number of patients with early gastric cancer; this is due to the technical difficulty in systematic lymph node dissection. For the treatment of advanced gastric cancer (AGC), in countries including Korea and Japan, gastrectomy with D2 lymph node dissection has been the standard operation. With the recent progress in diagnostic techniques, accumulation of experience with laparoscopy-assisted distal gastrectomy (LADG) for early gastric cancer and the increasing interest in a better quality of life, there has been an effort to apply minimally invasive techniques to the treatment of AGC. However, there has been no clinical trial to test the oncological feasibility of LADG with D2 lymph node dissection. There is only one phase-II study that evaluated whether the morbidity associated with LADG was higher than that of open gastrectomy.
Before the indications for LADG can be extended to include patients with advanced cancer, the status of surgical expertise for complete D2 lymph node dissection requires investigation using a prospective clinical study design. If this approach is shown to be feasible, a randomized prospective clinical trial, to compare survival and other surgical outcomes, would be the next step in validating this technique for this group of patients.
This study is to be performed according to the Helsinki Declaration. The study was approved by the Ethics Subcommittee at the National Cancer Center for Research Involving Human Subjects (no. NCCCTS-2005181). All patients will be provided written informed consent before entering the study.
Sample size The sample size was based on the alpha error at 0.05 and 90% of power and the accepted margin of the difference in the compliance rate at 10% based on a non-inferiority test. The target was chosen from the primary end point of the study. For the patients who underwent LADG with D2 lymph node dissection, the compliance rate-defined as cases in which there was no more than one missing lymph node station according to the guidelines of "The Japanese Research Society for Gastric Cancer" (JRSGC) lymph node grouping,11,12-was set up to 55%; for the patients with open distal gastrectomy with D2 lymph node dissection, it was 66%, based on a pilot study. We performed a pilot study to determine the compliance rate in 100 cases of open distal gastrectomy with D2 lymph node dissection before enrollment started. When the data was used for the formula, the total sample size required was determined to be 60 patients. When we added 10% for expected follow-up loss, the total sample size was calculated to be 66 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic D2 gastrectomy | Experimental | Procedure: Laparoscopic D2 distal gastrectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed adenocarcinoma of the stomach,
- Age between 18 and 75 years, performance status of ECOG 0-1
- Signed informed consent
- Location of the primary tumor in the antrum, angle and lower body
- No evidence of distant metastasis or invasion to adjacent organs or serosal infiltration,
Key exclusion criteria (3 listed)
- Metastatic disease, previous history of malignancy in any organ, any co-morbidity
- Obviating major surgery, contraindication to laparoscopy such as severe cardiac disease
- Abdominal wall hernias, diaphragmatic hernias, uncorrected coagulopathies, portal hypertension, pregnancy, previous upper abdominal surgery, complicated cases requiring emergency surgery, and an accompanying surgical condition requiring surgery at the same time
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 D2 distal gastrectomyAlso: LADGUnder general endotracheal anesthesia, Five or six ports are used. Lymph node dissection and ligation of vessels are carried out in the laparoscopic field. A partial omentectomy encompassing perigastric nodes is performed laparoscopically. D2 lymphadenectomy is carried out according to the guidelines of the "The Japanese Research Society for Gastric Cancer" for the corresponding location of the primary tumor. A 5- to 6-cm small incision is made transversely in RUQ of the abdomen. Through the incisional window, the stomach is removed from the abdominal cavity and resected. A Billroth-I gastroduodenostomy using an EEA stapler and GIA or a Billroth-II gastrojejunostomy with a hand-sewing technique is performed. The abdomen is then closed after hemostasis is achieved. | Procedure or surgery | Laparoscopic D2 gastrectomy |
Primary outcome
Compliance of lymph node dissection
Time frame: immediate postoperative 1 week
noncompliance : if two or more nodal station is vacant, it is a noncompliant D2 gastrectomy.
9 secondary outcomes
Proportion of patients with retrieved lymph nodes less than 26
Time frame: Postoperative 1 week
operative complications
Time frame: Postoperative 1 month
operative time
Time frame: postoperative 1 day
estimated blood loss
Time frame: postoperative 1 day
amount of administered analgesics
Time frame: Postoperative 1 week
time to diet
Time frame: postoperative 1 week
time to return of bowel movement
Time frame: postoperative 1 week
hospital stay
Time frame: postoperative 1 week
distance to resection margin and number of harvested lymph nodes
Time frame: postoperative 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2010.
- Background: PubMed 18340493Ryu KW, Kim YW, Lee JH, Nam BH, Kook MC, Choi IJ, Bae JM. Surgical complications and the risk factors of laparoscopy-assisted distal gastrectomy in early gastric cancer. Ann Surg Oncol. 2008 Jun;15(6):1625-31. doi: 10.1245/s10434-008-9845-x. Epub 2008 Mar 14.
- Results publication: PubMed 17705092Lee JH, Kim YW, Ryu KW, Lee JR, Kim CG, Choi IJ, Kook MC, Nam BH, Bae JM. A phase-II clinical trial of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for gastric cancer patients. Ann Surg Oncol. 2007 Nov;14(11):3148-53. doi: 10.1245/s10434-007-9446-0. Epub 2007 Aug 20.
- Results publication: PubMed 19430842Lee SE, Kim YW, Lee JH, Ryu KW, Cho SJ, Lee JY, Kim CG, Choi IJ, Kook MC, Nam BH, Park SR, Kim MJ, Lee JS. Developing an institutional protocol guideline for laparoscopy-assisted distal gastrectomy. Ann Surg Oncol. 2009 Aug;16(8):2231-6. doi: 10.1245/s10434-009-0490-9. Epub 2009 May 9.
Related trials for Gastric Cancer
RecruitingPhase 1/2
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Colorectal Cancer
Active, not recruitingPhase 2
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer, Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer
RecruitingPhase 1/2
CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Gastric/GEJ
RecruitingPhase 4
Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™)
Gastrointestinal Cancer, Gastric Cancer
RecruitingObservational study
Development and Utilization of an Integrated Clinical Genomic Database
Gastric Cancer, Colorectal Cancer
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. This study is not recruiting at the moment.
Young-Woo Kim, MD, PhD principal investigator
NCC Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laparoscopic D2 distal gastrectomy in people with Gastric Cancer, run by National Cancer Center, Korea 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 7 inclusion and 3 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: finished, as of the sponsor's last update on 19 Jul 2010. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance of lymph node dissection (time frame: immediate postoperative 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01163812, which also lists 3 linked publications.
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 Jul 2010.