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

NCT ID: NCT02748551

Last Updated: 2016-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2022-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer

Keywords

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Gastric cancer locally advanced gastric cancer laparoscopic surgery laparoscopic procedure comparison laparoscopic with open procedure multicenter trials

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laparoscopic surgery

Traditional open procedure for patient with locally advanced gastric cancer

Group Type EXPERIMENTAL

Open Surgery

Intervention Type PROCEDURE

Open surgery

Open surgery

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

Group Type ACTIVE_COMPARATOR

Laparoscopic procedures

Intervention Type PROCEDURE

Laparoscopic surgery

Interventions

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Laparoscopic procedures

Laparoscopic surgery

Intervention Type PROCEDURE

Open Surgery

Open surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Moscow Clinical Scientific Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michail Byachov, MD, PhD

Role: STUDY_CHAIR

Moscow Clinical Scientific Center

Roman Izrailov, MD, PhD

Role: STUDY_CHAIR

Moscow Clinical Scientific Center

Boris Pomortsev, MD

Role: PRINCIPAL_INVESTIGATOR

Moscow Clinical Scientific Center

Pavel Kononets, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Moscow Oncological Hospital 62

Andrey Ryabov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

P.Herzen Moscow Oncological Research Institute

Vladimir Lyadov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Treatment and Rehabilitation Centre of Health Ministry of Russia

Alexey Karachun, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

N. Petrov National Research Institute of Oncology

Victor Kashchenko, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Andrey Pavlenko, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Leningradsky oncological center

Michail Lando, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lipetsk regional oncological center

Sergey Baydo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lisod clinic Kiev

Igor Khatkov, MD, PhD

Role: STUDY_DIRECTOR

Moscow Clinical Scientific Center

Michail Prostov

Role: PRINCIPAL_INVESTIGATOR

Moscow Clinical Scientific Center

Kirill Schostka, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Leningradsky oncological center

Locations

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Lipetsk regional oncological center

Lipetsk, , Russia

Site Status RECRUITING

Moscow Clinical Scientific Center

Moscow, , Russia

Site Status RECRUITING

Moscow Oncology Hospital 62

Moscow, , Russia

Site Status RECRUITING

P.Herzen Moscow Oncological Research Institute

Moscow, , Russia

Site Status RECRUITING

Treatment and Rehabilitation Centre of Health Ministry of Russia

Moscow, , Russia

Site Status RECRUITING

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

Saint Petersburg, , Russia

Site Status RECRUITING

Leningradsky oncological center

Saint Petersburg, , Russia

Site Status RECRUITING

N. Petrov National Research Institute of Oncology

Saint Petersburg, , Russia

Site Status RECRUITING

Lisod clinic

Kiev, , Ukraine

Site Status RECRUITING

Countries

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Russia Ukraine

Central Contacts

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Igor Khathov, MD, PhD

Role: CONTACT

Phone: 8 (495) 3042908

Email: [email protected]

Roman Izrailov, MD, PhD

Role: CONTACT

Phone: 8 (495) 3042908

Email: [email protected]

Facility Contacts

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Michail Lando, MD, PhD

Role: primary

Roman Izrailov, MD, PhD

Role: primary

Boris Pomortsev, MD

Role: backup

Pavel Kononets

Role: primary

Andrey Ryabov, MD, PhD

Role: primary

Vladimir Lyadov, MD, PhD

Role: primary

Victor Kashchenko, MD, PhD

Role: primary

Andrey Pavlenko, MD, PhD

Role: primary

Alexey Karachun, MD, PhD

Role: primary

Sergey Baydo, MD, PhD

Role: primary

Other Identifiers

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MKNC 01/2016

Identifier Type: -

Identifier Source: org_study_id