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A Comparison Laparoscopic With Open Gastric Cancer Surgery for Locally Advanced Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Laparoscopic procedures
Open Surgery
Sponsored by
Moscow Clinical Scientific Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric cancer, locally advanced gastric cancer, laparoscopic surgery, laparoscopic procedure, comparison laparoscopic with open procedure, multicenter trials

Eligibility Criteria

18 Years - 82 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Lipetsk regional oncological centerRecruiting
  • Moscow Clinical Scientific CenterRecruiting
  • Moscow Oncology Hospital 62Recruiting
  • P.Herzen Moscow Oncological Research InstituteRecruiting
  • Treatment and Rehabilitation Centre of Health Ministry of RussiaRecruiting
  • Leningradsky oncological centerRecruiting
  • Federal Medical Biology Agence №122 the name of L.SokoRecruiting
  • N. Petrov National Research Institute of OncologyRecruiting
  • Lisod clinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic surgery

Open surgery

Arm Description

Traditional open procedure for patient with locally advanced gastric cancer

Minimum invasive procedure (laparoscopic) for patient with locally advanced gastric cancer

Outcomes

Primary Outcome Measures

"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.

Secondary Outcome Measures

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
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
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
Surgical Mortality
It is defined as the death within postoperative 90 days regardless of postoperative reason.
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.
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
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
Postoperative quality of life
Both the European Organization for Research and Treatment of Cancer (EORTC) C30 and STO22 are analyzed with quality of life
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.
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.

Full Information

First Posted
April 10, 2016
Last Updated
December 11, 2016
Sponsor
Moscow Clinical Scientific Center
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1. Study Identification

Unique Protocol Identification Number
NCT02748551
Brief Title
A Comparison Laparoscopic With Open Gastric Cancer Surgery for Locally Advanced Gastric Cancer
Official Title
Prospective Multicenter Study on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery for Locally Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Moscow Clinical Scientific Center

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric cancer, locally advanced gastric cancer, laparoscopic surgery, laparoscopic procedure, comparison laparoscopic with open procedure, multicenter trials

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic surgery
Arm Type
Experimental
Arm Description
Traditional open procedure for patient with locally advanced gastric cancer
Arm Title
Open surgery
Arm Type
Active Comparator
Arm Description
Minimum invasive procedure (laparoscopic) for patient with locally advanced gastric cancer
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic procedures
Intervention Description
Laparoscopic surgery
Intervention Type
Procedure
Intervention Name(s)
Open Surgery
Intervention Description
Open surgery
Primary Outcome Measure Information:
Title
"Major" Surgical Morbidity
Description
"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.
Time Frame
21 days.
Secondary Outcome Measure Information:
Title
3-year progression-free survival
Description
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
Time Frame
36 months
Title
3-year overall survival
Description
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
Time Frame
6, 12, 18, 24, 30 and 36 months
Title
5-year overall survival rate
Description
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
Time Frame
6, 12, 18, 24, 30, 36, 48 and 60 months
Title
Surgical Mortality
Description
It is defined as the death within postoperative 90 days regardless of postoperative reason.
Time Frame
90 days
Title
Peri-operative blood loss
Description
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.
Time Frame
1 day
Title
Postoperative recovery index
Description
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
Time Frame
10 days
Title
Pain scores
Description
Pain scores based on a visual analog scale the day of surgery and the subsequent 3 days postoperative 1 days, 2 days, 3 days
Time Frame
up to 3 days after surgery
Title
Postoperative quality of life
Description
Both the European Organization for Research and Treatment of Cancer (EORTC) C30 and STO22 are analyzed with quality of life
Time Frame
6, 12, 18, 24, 30 and 36 months
Title
long-term surgical morbidity
Description
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.
Time Frame
21days - 36 months after surgery
Title
Extent of lymph node dissection
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Igor Khathov, MD, PhD
Phone
8 (495) 3042908
Email
ihatkov@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Roman Izrailov, MD, PhD
Phone
8 (495) 3042908
Email
izrailev@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michail Byachov, MD, PhD
Organizational Affiliation
Moscow Clinical Scientific Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Roman Izrailov, MD, PhD
Organizational Affiliation
Moscow Clinical Scientific Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Boris Pomortsev, MD
Organizational Affiliation
Moscow Clinical Scientific Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pavel Kononets, MD, PhD
Organizational Affiliation
Moscow Oncological Hospital 62
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrey Ryabov, MD, PhD
Organizational Affiliation
P.Herzen Moscow Oncological Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vladimir Lyadov, MD, PhD
Organizational Affiliation
Treatment and Rehabilitation Centre of Health Ministry of Russia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexey Karachun, MD, PhD
Organizational Affiliation
N. Petrov National Research Institute of Oncology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Victor Kashchenko, MD, PhD
Organizational Affiliation
Federal Medical Biology Agence №122 the name of L.Sokolov
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrey Pavlenko, MD, PhD
Organizational Affiliation
Leningradsky oncological center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michail Lando, MD, PhD
Organizational Affiliation
Lipetsk regional oncological center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sergey Baydo, MD, PhD
Organizational Affiliation
Lisod clinic Kiev
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Igor Khatkov, MD, PhD
Organizational Affiliation
Moscow Clinical Scientific Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michail Prostov
Organizational Affiliation
Moscow Clinical Scientific Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kirill Schostka, MD, PhD
Organizational Affiliation
Leningradsky oncological center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lipetsk regional oncological center
City
Lipetsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michail Lando, MD, PhD
Email
abdlan@yandex.ru
Facility Name
Moscow Clinical Scientific Center
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roman Izrailov, MD, PhD
Phone
8 (495) 3042908
Email
izrailev@mail.ru
First Name & Middle Initial & Last Name & Degree
Boris Pomortsev, MD
Phone
8(915)2107630
Email
b.pomortsev@mknc.ru
First Name & Middle Initial & Last Name & Degree
Michail Prostov
Facility Name
Moscow Oncology Hospital 62
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavel Kononets
Email
p.kononets@onco62.ru
Facility Name
P.Herzen Moscow Oncological Research Institute
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrey Ryabov, MD, PhD
Email
ryabovdoc@mail.ru
Facility Name
Treatment and Rehabilitation Centre of Health Ministry of Russia
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir Lyadov, MD, PhD
Email
vlyadov@gmail.com
Facility Name
Leningradsky oncological center
City
St. Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrey Pavlenko, MD, PhD
Email
andrewpavlenko@yandex.ru
Facility Name
Federal Medical Biology Agence №122 the name of L.Soko
City
St.Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Kashchenko, MD, PhD
Email
med@fromru.com
Facility Name
N. Petrov National Research Institute of Oncology
City
St.Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexey Karachun, MD, PhD
Email
dr.a.karachun@gmail.com
Facility Name
Lisod clinic
City
Kiev
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergey Baydo, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

A Comparison Laparoscopic With Open Gastric Cancer Surgery for Locally Advanced Gastric Cancer

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