NCT02748551

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for phase_3 gastric-cancer

Timeline
Completed

Started Apr 2016

Typical duration for phase_3 gastric-cancer

Geographic Reach
2 countries

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

December 13, 2016

Status Verified

December 1, 2016

Enrollment Period

2 years

First QC Date

April 10, 2016

Last Update Submit

December 11, 2016

Conditions

Gastric Cancer

Keywords

Gastric cancerlocally advanced gastric cancerlaparoscopic surgerylaparoscopic procedurecomparison laparoscopic with open proceduremulticenter trials

Outcome Measures

Primary Outcomes (1)

  • "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.

    21 days.

Secondary Outcomes (10)

  • 3-year progression-free survival

    36 months

  • 3-year overall survival

    6, 12, 18, 24, 30 and 36 months

  • 5-year overall survival rate

    6, 12, 18, 24, 30, 36, 48 and 60 months

  • Surgical Mortality

    90 days

  • Peri-operative blood loss

    1 day

  • +5 more secondary outcomes

Study Arms (2)

Laparoscopic surgery

EXPERIMENTAL

Traditional open procedure for patient with locally advanced gastric cancer

Procedure: Open Surgery

Open surgery

ACTIVE COMPARATOR

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

Procedure: Laparoscopic procedures

Interventions

Laparoscopic proceduresPROCEDURE

Laparoscopic surgery

Open surgery
Open SurgeryPROCEDURE

Open surgery

Laparoscopic surgery

Eligibility Criteria

Age18 Years - 82 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Lipetsk regional oncological center

Lipetsk, Russia

RECRUITING

Moscow Clinical Scientific Center

Moscow, 111123, Russia

RECRUITING

Moscow Oncology Hospital 62

Moscow, Russia

RECRUITING

P.Herzen Moscow Oncological Research Institute

Moscow, Russia

RECRUITING

Treatment and Rehabilitation Centre of Health Ministry of Russia

Moscow, Russia

RECRUITING

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

Saint Petersburg, Russia

RECRUITING

Leningradsky oncological center

Saint Petersburg, Russia

RECRUITING

N. Petrov National Research Institute of Oncology

Saint Petersburg, Russia

RECRUITING

Lisod clinic

Kiev, Ukraine

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

LaparoscopyConversion to Open Surgery

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Michail Byachov, MD, PhD

    Moscow Clinical Scientific Center

    STUDY CHAIR

  • Roman Izrailov, MD, PhD

    Moscow Clinical Scientific Center

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

  • Igor Khatkov, MD, PhD

    Moscow Clinical Scientific Center

    STUDY DIRECTOR

  • Michail Prostov

    Moscow Clinical Scientific Center

    PRINCIPAL INVESTIGATOR

  • Kirill Schostka, MD, PhD

    Leningradsky oncological center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Igor Khathov, MD, PhD

CONTACT

8 (495) 3042908ihatkov@gmail.com

Roman Izrailov, MD, PhD

CONTACT

8 (495) 3042908izrailev@mail.ru

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2016

First Posted

April 22, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2022

Last Updated

December 13, 2016

Record last verified: 2016-12

Locations

UA(1)RU(8)