Gastric CancerPhase 2NCT02311595
A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection
A Phase 2 study testing reduced port laparoscopic distal gastrectomy in people with Gastric Cancer, run by Samsung Medical Center.
Trial summary
The purpose of this study is to determine if reduced port totally laparoscopic distal gastrectomy with complete D2 lymph node dissection for gastric cancer is safe and oncological feasible. 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?
- reduced port laparoscopic distal gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Mar 2015
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed adenocarcinoma of the stomach
- Eastern Cooperative Oncology Group Eastern Cooperative Oncology Group performance status 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
Who cannot join
- metastatic disease
- previous history of malignancy in any organ
- any co-morbidity obviating major surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection for Gastric Cancer Patients
The purpose of this study is to determine if reduced port totally laparoscopic distal gastrectomy with complete D2 lymph node dissection for gastric cancer is safe and oncological feasible.
67 patients with gastric cancer with preoperative staging from T1 to T3 will undergo reduced port totally laparoscopic distal gastrectomy.
The primary end point of this study is to measure compliance rate with pathology report and compare with previous compliance rate data.
- Conditions
- Gastric Cancer
- Being tested
- reduced port laparoscopic distal gastrectomy
- Keywords
- gastric cancer, laparoscope
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reduced port laparoscopic distal gastrectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| reduced port | Experimental | gastric cancer patients go through reduced port laparoscopic distal gastrectomy with D2 lymph node dissection Receives: Procedure: reduced port laparoscopic distal gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance rate (Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping)
Compliance rate : Cases with no more than one missing lymph node station according to the Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping
Measured: 1 month after enrollment of the patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
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.
- More trials run by Samsung Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Ho Lee, M.D. ph.D, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311595
- Sponsor's protocol ID
- 2014-10-032
- Status last verified
- Dec 2014
- First submitted
- 4 Dec 2014
- Last updated
- 8 Dec 2014
- Results posted
- No
Publications
Lee 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 17705092Kim SM, Lee JH, Lee SH, Ha MH, Seo JE, Kim JE, Choi MG, Sohn TS, Bae JM, Kim S. Techniques of reduced PRT laparoscopy-assisted distal gastrectomy (duet LADG). Ann Surg Oncol. 2015 Mar;22(3):793. doi: 10.1245/s10434-014-4087-6. Epub 2014 Sep 17.
PubMed 25227307Bonenkamp JJ, Hermans J, Sasako M, van de Velde CJ, Welvaart K, Songun I, Meyer S, Plukker JT, Van Elk P, Obertop H, Gouma DJ, van Lanschot JJ, Taat CW, de Graaf PW, von Meyenfeldt MF, Tilanus H; Dutch Gastric Cancer Group. Extended lymph-node dissection for gastric cancer. N Engl J Med. 1999 Mar 25;340(12):908-14. doi: 10.1056/NEJM199903253401202.
PubMed 10089184
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection for Gastric Cancer Patients
- ClinicalTrials.gov ID
- NCT02311595
- Acronym / sponsor ID
- 2014-10-032
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, laparoscope
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 8 Dec 2014 (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.
The purpose of this study is to determine if reduced port totally laparoscopic distal gastrectomy with complete D2 lymph node dissection for gastric cancer is safe and oncological feasible.
67 patients with gastric cancer with preoperative staging from T1 to T3 will undergo reduced port totally laparoscopic distal gastrectomy.
The primary end point of this study is to measure compliance rate with pathology report and compare with previous compliance rate data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| reduced port | Experimental | Procedure: reduced port laparoscopic distal gastrectomygastric cancer patients go through reduced port laparoscopic distal gastrectomy with D2 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 (5 listed)
- histologically confirmed adenocarcinoma of the stomach
- Eastern Cooperative Oncology Group Eastern Cooperative Oncology Group performance status 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
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 |
|---|---|---|
| reduced port laparoscopic distal gastrectomy | Procedure or surgery | reduced port |
Primary outcome
Compliance rate (Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping)
Time frame: 1 month after enrollment of the patients
Compliance rate : Cases with no more than one missing lymph node station according to the Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
- Background: 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.
- Background: PubMed 25227307Kim SM, Lee JH, Lee SH, Ha MH, Seo JE, Kim JE, Choi MG, Sohn TS, Bae JM, Kim S. Techniques of reduced PRT laparoscopy-assisted distal gastrectomy (duet LADG). Ann Surg Oncol. 2015 Mar;22(3):793. doi: 10.1245/s10434-014-4087-6. Epub 2014 Sep 17.
- Background: PubMed 10089184Bonenkamp JJ, Hermans J, Sasako M, van de Velde CJ, Welvaart K, Songun I, Meyer S, Plukker JT, Van Elk P, Obertop H, Gouma DJ, van Lanschot JJ, Taat CW, de Graaf PW, von Meyenfeldt MF, Tilanus H; Dutch Gastric Cancer Group. Extended lymph-node dissection for gastric cancer. N Engl J Med. 1999 Mar 25;340(12):908-14. doi: 10.1056/NEJM199903253401202.
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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. This study is not recruiting at the moment.
Jun Ho Lee, M.D. ph.D study chair
Samsung Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing reduced port laparoscopic distal gastrectomy in people with Gastric Cancer, run by Samsung Medical Center.
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 5 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: status not confirmed, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Ho Lee, M.D. ph.D (82-2-3410-3463, gsjunholee@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance rate (Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping) (time frame: 1 month after enrollment of the patients). 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 NCT02311595, 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 8 Dec 2014.