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Trial record 4 of 30 for:    cancer | First posted from 04/22/2016 to 04/22/2016

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

This study is currently recruiting participants.
Verified December 2016 by Moscow Clinical Scientific Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02748551
First Posted: April 22, 2016
Last Update Posted: December 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Moscow Clinical Scientific Center
  Purpose

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.


Condition Intervention Phase
Gastric Cancer Procedure: Laparoscopic procedures Procedure: Open Surgery Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Multicenter Study on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery for Locally Advanced Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Moscow Clinical Scientific Center:

Primary Outcome Measures:
  • "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.


Secondary Outcome Measures:
  • 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

  • 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

  • 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

  • Surgical Mortality [ Time Frame: 90 days ]
    It is defined as the death within postoperative 90 days regardless of postoperative reason.

  • 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.

  • 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

  • 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

  • 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

  • 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.

  • 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.


Estimated Enrollment: 800
Study Start Date: April 2016
Estimated Study Completion Date: April 2022
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 82 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02748551


Contacts
Contact: Igor Khathov, MD, PhD 8 (495) 3042908 ihatkov@gmail.com
Contact: Roman Izrailov, MD, PhD 8 (495) 3042908 izrailev@mail.ru

Locations
Russian Federation
Lipetsk regional oncological center Recruiting
Lipetsk, Russian Federation
Contact: Michail Lando, MD, PhD       abdlan@yandex.ru   
Moscow Clinical Scientific Center Recruiting
Moscow, Russian Federation, 111123
Contact: Roman Izrailov, MD, PhD    8 (495) 3042908    izrailev@mail.ru   
Contact: Boris Pomortsev, MD    8(915)2107630    b.pomortsev@mknc.ru   
Sub-Investigator: Michail Prostov         
Moscow Oncology Hospital 62 Recruiting
Moscow, Russian Federation
Contact: Pavel Kononets       p.kononets@onco62.ru   
P.Herzen Moscow Oncological Research Institute Recruiting
Moscow, Russian Federation
Contact: Andrey Ryabov, MD, PhD       ryabovdoc@mail.ru   
Treatment and Rehabilitation Centre of Health Ministry of Russia Recruiting
Moscow, Russian Federation
Contact: Vladimir Lyadov, MD, PhD       vlyadov@gmail.com   
Leningradsky oncological center Recruiting
St. Petersburg, Russian Federation
Contact: Andrey Pavlenko, MD, PhD       andrewpavlenko@yandex.ru   
Federal Medical Biology Agence №122 the name of L.Soko Recruiting
St.Petersburg, Russian Federation
Contact: Victor Kashchenko, MD, PhD       med@fromru.com   
N. Petrov National Research Institute of Oncology Recruiting
St.Petersburg, Russian Federation
Contact: Alexey Karachun, MD, PhD       dr.a.karachun@gmail.com   
Ukraine
Lisod clinic Recruiting
Kiev, Ukraine
Contact: Sergey Baydo, MD, PhD         
Sponsors and Collaborators
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
  More Information

Responsible Party: Moscow Clinical Scientific Center
ClinicalTrials.gov Identifier: NCT02748551     History of Changes
Other Study ID Numbers: MKNC 01/2016
First Submitted: April 10, 2016
First Posted: April 22, 2016
Last Update Posted: December 13, 2016
Last Verified: December 2016

Keywords provided by Moscow Clinical Scientific Center:
Gastric cancer
locally advanced gastric cancer
laparoscopic surgery
laparoscopic procedure
comparison laparoscopic with open procedure
multicenter trials

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases