Clinical trial NCT02748551: A Comparison Laparoscopic With Open Gastric Cancer Surgery for Locally Advanced Gastric Cancer
Official title: Prospective Multicenter Study on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery for Locally Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: Gastric cancer
locally advanced gastric cancer
laparoscopic surgery
laparoscopic procedure
comparison laparoscopic with open procedure
multicenter trials
Lead sponsor: Moscow Clinical Scientific Center
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: "Major" Surgical Morbidity
timeFrame: 21 days.
Secondary outcomes:
measure: 3-year progression-free survival
timeFrame: 36 months
measure: 3-year overall survival
timeFrame: 6, 12, 18, 24, 30 and 36 months
measure: 5-year overall survival rate
timeFrame: 6, 12, 18, 24, 30, 36, 48 and 60 months
measure: Surgical Mortality
timeFrame: 90 days
measure: Peri-operative blood loss
timeFrame: 1 day
measure: Postoperative recovery index
timeFrame: 10 days
measure: Pain scores
timeFrame: up to 3 days after surgery
measure: Postoperative quality of life
timeFrame: 6, 12, 18, 24, 30 and 36 months
measure: long-term surgical morbidity
timeFrame: 21days - 36 months after surgery
measure: Extent of lymph node dissection
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Lipetsk
country: Russian Federation
facility: Lipetsk regional oncological center
city: Moscow
country: Russian Federation
facility: Moscow Clinical Scientific Center
city: Moscow
country: Russian Federation
facility: Moscow Oncology Hospital 62
city: Moscow
country: Russian Federation
facility: P.Herzen Moscow Oncological Research Institute
city: Moscow
country: Russian Federation
facility: Treatment and Rehabilitation Centre of Health Ministry of Russia
city: St. Petersburg
country: Russian Federation
facility: Leningradsky oncological center
city: St.Petersburg
country: Russian Federation
facility: Federal Medical Biology Agence №122 the name of L.Soko
city: St.Petersburg
country: Russian Federation
facility: N. Petrov National Research Institute of Oncology
city: Kiev
country: Ukraine
facility: Lisod clinic
Study officials:
affiliation: Moscow Clinical Scientific Center
name: Michail Byachov, MD, PhD
role: STUDY_CHAIR
affiliation: Moscow Clinical Scientific Center
name: Roman Izrailov, MD, PhD
role: STUDY_CHAIR
affiliation: Moscow Clinical Scientific Center
name: Boris Pomortsev, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Moscow Oncological Hospital 62
name: Pavel Kononets, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: P.Herzen Moscow Oncological Research Institute
name: Andrey Ryabov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Treatment and Rehabilitation Centre of Health Ministry of Russia
name: Vladimir Lyadov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: N. Petrov National Research Institute of Oncology
name: Alexey Karachun, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal Medical Biology Agence №122 the name of L.Sokolov
name: Victor Kashchenko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Leningradsky oncological center
name: Andrey Pavlenko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lipetsk regional oncological center
name: Michail Lando, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lisod clinic Kiev
name: Sergey Baydo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Moscow Clinical Scientific Center
name: Igor Khatkov, MD, PhD
role: STUDY_DIRECTOR
affiliation: Moscow Clinical Scientific Center
name: Michail Prostov
role: PRINCIPAL_INVESTIGATOR
affiliation: Leningradsky oncological center
name: Kirill Schostka, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: