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

Last updated: December 11, 2016
Sponsor: Moscow Clinical Scientific Center
Overall Status: Active - Recruiting

Phase

3

Condition

Digestive System Neoplasms

Stomach Cancer

Gastric Cancer

Treatment

N/A

Clinical Study ID

NCT02748551
MKNC 01/2016
  • Ages 18-82
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ECOG 0-1

  • ASA I-III

  • Histologically proven cancer of the stomach cT 2-4a(clinical stage tumor), N0-3, M0 atpreoperative evaluation according to the American Joint Committee on Cancer (AJCC)Cancer Staging Manual Seventh Edition

  • Preoperative examination with no distant metastasis, no significantly enlarged lymphnodes 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 bysubtotal or total gastrectomy with D2 lymph node dissection.

  • Written informed consent

Exclusion

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 Design

Total Participants: 800
Study Start date:
April 01, 2016
Estimated Completion Date:
April 30, 2022

Connect with a study center

  • Lipetsk regional oncological center

    Lipetsk,
    Russian Federation

    Active - Recruiting

  • Moscow Clinical Scientific Center

    Moscow, 111123
    Russian Federation

    Active - Recruiting

  • Moscow Oncology Hospital 62

    Moscow,
    Russian Federation

    Active - Recruiting

  • P.Herzen Moscow Oncological Research Institute

    Moscow,
    Russian Federation

    Active - Recruiting

  • Treatment and Rehabilitation Centre of Health Ministry of Russia

    Moscow,
    Russian Federation

    Active - Recruiting

  • Leningradsky oncological center

    St. Petersburg,
    Russian Federation

    Active - Recruiting

  • Federal Medical Biology Agence №122 the name of L.Soko

    St.Petersburg,
    Russian Federation

    Active - Recruiting

  • N. Petrov National Research Institute of Oncology

    St.Petersburg,
    Russian Federation

    Active - Recruiting

  • Lisod clinic

    Kiev,
    Ukraine

    Active - Recruiting

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