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

Gastric Cancer Clinical Trial

Official title:

Prospective Multicenter Study on Laparoscopic Gastric Cancer Surgery Compared With Open Surgery for Locally Advanced Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02748551
• Other study ID #: MKNC 01/2016
• Status: Recruiting
• Phase: Phase 3
• First received: April 10, 2016
• Last updated: December 11, 2016
• Start date: April 2016
• Est. completion date: April 2022

Study information

• Verified date: December 2016
• Source: Moscow Clinical Scientific Center
• Contact: Igor Khathov, MD, PhD
• Phone: 8 (495) 3042908
• Email: ihatkov[@]gmail.com
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: April 2022
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 82 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Laparoscopic procedures
Laparoscopic surgery
• Open Surgery
Open surgery

Locations

Country	Name	City	State
Russian Federation	Lipetsk regional oncological center	Lipetsk
Russian Federation	Moscow Clinical Scientific Center	Moscow
Russian Federation	Moscow Oncology Hospital 62	Moscow
Russian Federation	P.Herzen Moscow Oncological Research Institute	Moscow
Russian Federation	Treatment and Rehabilitation Centre of Health Ministry of Russia	Moscow
Russian Federation	Leningradsky oncological center	St. Petersburg
Russian Federation	Federal Medical Biology Agence ?122 the name of L.Soko	St.Petersburg
Russian Federation	N. Petrov National Research Institute of Oncology	St.Petersburg
Ukraine	Lisod clinic	Kiev

Sponsors (1)

Lead Sponsor	Collaborator
Moscow Clinical Scientific Center

Countries where clinical trial is conducted

Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"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.	Yes
Secondary	3-year progression-free survival	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	36 months	Yes
Secondary	3-year overall survival	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	6, 12, 18, 24, 30 and 36 months	No
Secondary	5-year overall survival rate	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	6, 12, 18, 24, 30, 36, 48 and 60 months	No
Secondary	Surgical Mortality	It is defined as the death within postoperative 90 days regardless of postoperative reason.	90 days	Yes
Secondary	Peri-operative blood loss	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.	1 day	No
Secondary	Postoperative recovery index	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	10 days	No
Secondary	Pain scores	Pain scores based on a visual analog scale the day of surgery and the subsequent 3 days postoperative 1 days, 2 days, 3 days	up to 3 days after surgery	No
Secondary	Postoperative quality of life	Both the European Organization for Research and Treatment of Cancer (EORTC) C30 and STO22 are analyzed with quality of life	6, 12, 18, 24, 30 and 36 months	No
Secondary	long-term surgical morbidity	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.	21days - 36 months after surgery	No
Secondary	Extent of lymph node dissection	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.	2 weeks	Yes