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

December 11, 2016 updated by: Moscow Clinical Scientific Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Lipetsk, Russian Federation
        • Recruiting
        • Lipetsk regional oncological center
        • Contact:
      • Moscow, Russian Federation, 111123
        • Recruiting
        • Moscow Clinical Scientific Center
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Michail Prostov
      • Moscow, Russian Federation
      • Moscow, Russian Federation
        • Recruiting
        • P.Herzen Moscow Oncological Research Institute
        • Contact:
      • Moscow, Russian Federation
        • Recruiting
        • Treatment and Rehabilitation Centre of Health Ministry of Russia
        • Contact:
      • St. Petersburg, Russian Federation
      • St.Petersburg, Russian Federation
        • Recruiting
        • Federal Medical Biology Agence №122 the name of L.Soko
        • Contact:
      • St.Petersburg, Russian Federation
        • Recruiting
        • N. Petrov National Research Institute of Oncology
        • Contact:
  • Ukraine
      • Kiev, Ukraine
        • Recruiting
        • Lisod clinic
        • Contact:
          • Sergey Baydo, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 82 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laparoscopic surgery
Traditional open procedure for patient with locally advanced gastric cancer
Procedure: Open Surgery
Open surgery
Active Comparator: Open surgery
Minimum invasive procedure (laparoscopic) for patient with locally advanced gastric cancer
Procedure: Laparoscopic procedures
Laparoscopic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"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.
21 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year progression-free survival
Time Frame: 36 months
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
36 months
3-year overall survival
Time Frame: 6, 12, 18, 24, 30 and 36 months
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
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
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
6, 12, 18, 24, 30, 36, 48 and 60 months
Surgical Mortality
Time Frame: 90 days
It is defined as the death within postoperative 90 days regardless of postoperative reason.
90 days
Peri-operative blood loss
Time Frame: 1 day
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.
1 day
Postoperative recovery index
Time Frame: 10 days
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
10 days
Pain scores
Time Frame: up to 3 days after surgery
Pain scores based on a visual analog scale the day of surgery and the subsequent 3 days postoperative 1 days, 2 days, 3 days
up to 3 days after surgery
Postoperative quality of life
Time Frame: 6, 12, 18, 24, 30 and 36 months
Both the European Organization for Research and Treatment of Cancer (EORTC) C30 and STO22 are analyzed with quality of life
6, 12, 18, 24, 30 and 36 months
long-term surgical morbidity
Time Frame: 21days - 36 months after surgery
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.
21days - 36 months after surgery
Extent of lymph node dissection
Time Frame: 2 weeks
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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moscow Clinical Scientific Center

Investigators

  • Study Chair: Michail Byachov, MD, PhD, Moscow Clinical Scientific Center
  • Study Chair: Roman Izrailov, MD, PhD, Moscow Clinical Scientific Center
  • Principal Investigator: Boris Pomortsev, MD, Moscow Clinical Scientific Center
  • Principal Investigator: Pavel Kononets, MD, PhD, Moscow Oncological Hospital 62
  • Principal Investigator: Andrey Ryabov, MD, PhD, P.Herzen Moscow Oncological Research Institute
  • Principal Investigator: Vladimir Lyadov, MD, PhD, Treatment and Rehabilitation Centre of Health Ministry of Russia
  • Principal Investigator: Alexey Karachun, MD, PhD, N. Petrov National Research Institute of Oncology
  • Principal Investigator: Victor Kashchenko, MD, PhD, Federal Medical Biology Agence №122 the name of L.Sokolov
  • Principal Investigator: Andrey Pavlenko, MD, PhD, Leningradsky oncological center
  • Principal Investigator: Michail Lando, MD, PhD, Lipetsk regional oncological center
  • Principal Investigator: Sergey Baydo, MD, PhD, Lisod clinic Kiev
  • Study Director: Igor Khatkov, MD, PhD, Moscow Clinical Scientific Center
  • Principal Investigator: Michail Prostov, Moscow Clinical Scientific Center
  • Principal Investigator: Kirill Schostka, MD, PhD, Leningradsky oncological center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

April 10, 2016

First Submitted That Met QC Criteria

April 19, 2016

First Posted (Estimate)

April 22, 2016

Study Record Updates

Last Update Posted (Estimate)

December 13, 2016

Last Update Submitted That Met QC Criteria

December 11, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MKNC 01/2016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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