Gastric CancerPhase 3NCT02748551
A Comparison Laparoscopic With Open Gastric Cancer Surgery for Locally Advanced Gastric Cancer
A Phase 3 study testing Laparoscopic procedures and Open Surgery in people with Gastric Cancer, run by Moscow Clinical Scientific Center at 9 sites in 2 countries.
Trial summary
Nowadays, the proportion of patients with locally advanced gastric cancer is estimated up to 90 percent of all gastric cancer cases in Russian Federation. Surgical procedure with D2 Lymphadenectomy is the main option for treatment. Conventional open approach is still the current standard for advanced gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 82 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Laparoscopic procedures and Open Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Apr 2016to Apr 2022
- Phase
- Phase 3
- 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 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG 0-1
- ASA I-III
- Histologically proven cancer of the stomach cT 2-4a(clinical stage tumor), N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
- Preoperative examination with no distant metastasis, no significantly enlarged lymph nodes around abdominal main artery, and tumor not a direct violation of the pancreas, spleen and other surrounding organs
- The gastric tumors are located in the stomach, are macroscopically resectable by subtotal or total gastrectomy with D2 lymph node dissection.
- Written informed consent
Who cannot join
- Clinically apparent distant metastasis
- Free cancer cells
- Bulky lymph node metastasis is detected by abdominal CT
- Previous treatment with radiation therapy for any tumors.
- Previous surgery for the present disease
- Pregnancy
- Psychiatric disease
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Russia8 sites, 8 recruiting
- Recruiting
Lipetsk regional oncological center
Lipetsk
Michail Lando, MD, PhD, abdlan@yandex.ru
- Recruiting
Moscow Clinical Scientific Center
Moscow, 111123
Roman Izrailov, MD, PhD, 8 (495) 3042908, izrailev@mail.ru
Boris Pomortsev, MD, 8(915)2107630, b.pomortsev@mknc.ru
- Recruiting
Moscow Oncology Hospital 62
Moscow
Pavel Kononets, p.kononets@onco62.ru
- Recruiting
P.Herzen Moscow Oncological Research Institute
Moscow
Andrey Ryabov, MD, PhD, ryabovdoc@mail.ru
- Recruiting
Treatment and Rehabilitation Centre of Health Ministry of Russia
Moscow
Vladimir Lyadov, MD, PhD, vlyadov@gmail.com
- Recruiting
Federal Medical Biology Agence №122 the name of L.Soko
Saint Petersburg
Victor Kashchenko, MD, PhD, med@fromru.com
- Recruiting
Leningradsky oncological center
Saint Petersburg
Andrey Pavlenko, MD, PhD, andrewpavlenko@yandex.ru
- Recruiting
N. Petrov National Research Institute of Oncology
Saint Petersburg
Alexey Karachun, MD, PhD, dr.a.karachun@gmail.com
About this study
Official title: Prospective Multicenter Study on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery for Locally Advanced Gastric Cancer
Nowadays, the proportion of patients with locally advanced gastric cancer is estimated up to 90 percent of all gastric cancer cases in Russian Federation. Surgical procedure with D2 Lymphadenectomy is the main option for treatment. Conventional open approach is still the current standard for advanced gastric cancer. Laparoscopic procedures for gastric cancer as minimally invasive surgery has gained popularity for the treatment of early gastric cancer in East Asia. Several studies indicated that laparoscopic procedures both total and subtotal gastrectomy with D2 lymphadenectomy is a technically feasible and safe procedure by experienced surgeons in high-volume specialized hospitals. However, lack of solid evidence on the oncologic efficacy.
Starting clinical trials for evaluate safety of oncology laparoscopic subtotal gastrectomy for locally advanced gastric cancer. Aim of this trial is show safety, feasibility and oncologic efficacy of Laparoscopic radical surgical procedures both total and subtotal gastrectomy for treatment gastric cancer.
- Conditions
- Gastric Cancer
- Being tested
- Laparoscopic procedures, Open Surgery
- Keywords
- Gastric cancer, locally advanced gastric cancer, laparoscopic surgery, laparoscopic procedure, comparison laparoscopic with open procedure, multicenter trials
- 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 proceduresProcedure or surgery
Laparoscopic surgery
Open SurgeryProcedure or surgery
Open surgery
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic surgery | Experimental | Traditional open procedure for patient with locally advanced gastric cancer Receives: Procedure: Open Surgery |
| Open surgery | Active comparator | Minimum invasive procedure (laparoscopic) for patient with locally advanced gastric cancer Receives: Procedure: Laparoscopic procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Major" Surgical Morbidity
"Major" Surgical morbidity is defined as the complication grade on III-V Clavien-Dindo Classification which occurs with-in postoperative 21 days, extension of hospitalization and re-hospitalization. It is necessary to evaluate the complication and if it occurs during the hospitalization, it is required to record complication name, date of on-set (postoperatively), grade on Clavien-Dindo Classification and treatment for complication.
Measured: 21 days.
Secondary outcomes (10)
3-year progression-free survival
In terms of locally advanced gastric cancer, to evaluate the progression-free survival rate in laparoscopic gastrectomy with D2 lymph node dissection at postoperative 3 years compared with open procedures
Measured: 36 months
3-year overall survival
In terms of locally advanced gastric cancer, to evaluate the overall survival rate in laparoscopic gastrectomy with D2 lymph node dissection at postoperative 3 years compared with open procedures
Measured: 6, 12, 18, 24, 30 and 36 months
5-year overall survival rate
In terms of locally advanced gastric cancer, to evaluate the overall survival rate in laparoscopic gastrectomy with D2 lymph node dissection at postoperative 5 years compared with open procedures
Measured: 6, 12, 18, 24, 30, 36, 48 and 60 months
Surgical Mortality
It is defined as the death within postoperative 90 days regardless of postoperative reason.
Measured: 90 days
Peri-operative blood loss
Minimally-invasive surgery is associated with less peri-operative blood loss. Blood loss will be measured in milliliters and average blood loss will be compared to the conventional 'open' group.
Measured: 1 day
Postoperative recovery index
Time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay are used to assess the postoperative recovery course The amount of abdominal drainage and blood transfusion are also recorded
Measured: 10 days
Pain scores
Pain scores based on a visual analog scale the day of surgery and the subsequent 3 days postoperative 1 days, 2 days, 3 days
Measured: up to 3 days after surgery
Postoperative quality of life
Both the European Organization for Research and Treatment of Cancer (EORTC) C30 and STO22 are analyzed with quality of life
Measured: 6, 12, 18, 24, 30 and 36 months
long-term surgical morbidity
Surgical morbidity is defined as the events which occurs with-in postoperative 21 days - 36 months after surgery. It is necessary to evaluate the complication, it is required to record complication name, date of on-set. Long complications are included: hernia, bleeding, bowel obstruction etc.
Measured: 21days - 36 months after surgery
Extent of lymph node dissection
The extent of lymph node dissection in treatment of gastric cancer is considered a prognostic marker for postoperative survival and disease-free survival. Before implementation of a new surgical technique, it is imperative that this technique is non-inferior with regard to the extent of lymph node dissection. Measures will include the number of resected lymph nodes and the number of resected lymph node stations.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2018 (estimated)
- Study completionApr 2022 (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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moscow Clinical Scientific Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michail Byachov, MD, PhD, Study chair, Moscow Clinical Scientific CenterRoman Izrailov, MD, PhD, Study chair, Moscow Clinical Scientific CenterBoris Pomortsev, MD, Principal investigator, Moscow Clinical Scientific CenterPavel Kononets, MD, PhD, Principal investigator, Moscow Oncological Hospital 62Andrey Ryabov, MD, PhD, Principal investigator, P.Herzen Moscow Oncological Research InstituteVladimir Lyadov, MD, PhD, Principal investigator, Treatment and Rehabilitation Centre of Health Ministry of RussiaAlexey Karachun, MD, PhD, Principal investigator, N. Petrov National Research Institute of OncologyVictor Kashchenko, MD, PhD, Principal investigator, Federal Medical Biology Agence №122 the name of L.Sokolov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748551
- Sponsor's protocol ID
- MKNC 01/2016
- Status last verified
- Dec 2016
- First submitted
- 10 Apr 2016
- Last updated
- 13 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Study on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery for Locally Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT02748551
- Acronym / sponsor ID
- MKNC 01/2016
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, locally advanced gastric cancer, laparoscopic surgery, laparoscopic procedure, comparison laparoscopic with open procedure, multicenter trials
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Moscow Clinical Scientific CenterUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 22 Apr 2016 (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.
Nowadays, the proportion of patients with locally advanced gastric cancer is estimated up to 90 percent of all gastric cancer cases in Russian Federation. Surgical procedure with D2 Lymphadenectomy is the main option for treatment. Conventional open approach is still the current standard for advanced gastric cancer. Laparoscopic procedures for gastric cancer as minimally invasive surgery has gained popularity for the treatment of early gastric cancer in East Asia. Several studies indicated that laparoscopic procedures both total and subtotal gastrectomy with D2 lymphadenectomy is a technically feasible and safe procedure by experienced surgeons in high-volume specialized hospitals. However, lack of solid evidence on the oncologic efficacy.
Starting clinical trials for evaluate safety of oncology laparoscopic subtotal gastrectomy for locally advanced gastric cancer. Aim of this trial is show safety, feasibility and oncologic efficacy of Laparoscopic radical surgical procedures both total and subtotal gastrectomy for treatment gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic surgery | Experimental | Procedure: Open SurgeryTraditional open procedure for patient with locally advanced gastric cancer |
| Open surgery | Active comparator | Procedure: Laparoscopic proceduresMinimum invasive procedure (laparoscopic) for patient with locally advanced gastric cancer |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ECOG 0-1
- ASA I-III
- Histologically proven cancer of the stomach cT 2-4a(clinical stage tumor), N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
- Preoperative examination with no distant metastasis, no significantly enlarged lymph nodes around abdominal main artery, and tumor not a direct violation of the pancreas, spleen and other surrounding organs
- The gastric tumors are located in the stomach, are macroscopically resectable by subtotal or total gastrectomy with D2 lymph node dissection.
Key exclusion criteria (7 listed)
- Clinically apparent distant metastasis
- Free cancer cells
- Bulky lymph node metastasis is detected by abdominal CT
- Previous treatment with radiation therapy for any tumors.
- Previous surgery for the present disease
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 proceduresLaparoscopic surgery | Procedure or surgery | Open surgery |
| Open SurgeryOpen surgery | Procedure or surgery | Laparoscopic surgery |
Primary outcome
"Major" Surgical Morbidity
Time frame: 21 days.
"Major" Surgical morbidity is defined as the complication grade on III-V Clavien-Dindo Classification which occurs with-in postoperative 21 days, extension of hospitalization and re-hospitalization. It is necessary to evaluate the complication and if it occurs during the hospitalization, it is required to record complication name, date of on-set (postoperatively), grade on Clavien-Dindo Classification and treatment for complication.
10 secondary outcomes
3-year progression-free survival
Time frame: 36 months
3-year overall survival
Time frame: 6, 12, 18, 24, 30 and 36 months
5-year overall survival rate
Time frame: 6, 12, 18, 24, 30, 36, 48 and 60 months
Surgical Mortality
Time frame: 90 days
Peri-operative blood loss
Time frame: 1 day
Postoperative recovery index
Time frame: 10 days
Pain scores
Time frame: up to 3 days after surgery
Postoperative quality of life
Time frame: 6, 12, 18, 24, 30 and 36 months
long-term surgical morbidity
Time frame: 21days - 36 months after surgery
Extent of lymph node dissection
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
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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.
Michail Byachov, MD, PhD study chair
Moscow Clinical Scientific Center
Roman Izrailov, MD, PhD study chair
Moscow Clinical Scientific Center
Boris Pomortsev, MD principal investigator
Moscow Clinical Scientific Center
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Laparoscopic procedures and Open Surgery in people with Gastric Cancer, run by Moscow Clinical Scientific Center at 9 sites in 2 countries.
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 6 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: status not confirmed, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Russia, Ukraine. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Igor Khathov, MD, PhD (8 (495) 3042908, ihatkov@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Major" Surgical Morbidity (time frame: 21 days.). 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 13 Dec 2016.