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A Trial of Total Versus Partial Omentectomy for Advanced Gastric Cancer in Gastrectomy (TOP1)

Primary Purpose

Gastric Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Type of omentectomy
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, Omentectomy, Prognosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Had been treated with Radical resection (D2, R0) of gastric cancer (Lymph node≥16);
  2. Physical condition and organ function allows to tolerable abdominal surgery;
  3. Willing and able to comply with the program during the study period;
  4. Written informed consent provided;
  5. ≥ 18 and ≤ 70 years of age; preoperative gastric cancer patients with pathologically confirmed;
  6. With more than a 6-month life expectancy;
  7. No other serious concomitant diseases; Sufficient organ functions;
  8. No previous history of chemotherapy or radiotherapy;
  9. All patients accept 8 cycles XELOX chemotherapy regimen;
  10. Clinical stage: T2-4aN0-+M0;
  11. Macroscopic types :Borrmann I-III;
  12. Not greater curvature tumor;
  13. No previous surgery for any abdominal disease, except an appendectomy for appendicitis, a laparoscopic cholecystectomy for gallbladder stones; No previous history of peritonitis, pancreatitis;
  14. Karnofsky performance status (KPS)>60; Eastern Cooperative Oncology Group Performance Status (ECOG): 0-1.

Exclusion Criteria:

  1. Pregnancy or breast feeding;
  2. Patients with Serious liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, hypertension and other chronic systemic diseases, heart disease with Clinical symptoms, such as congestive heart failure, coronary heart disease symptoms, drug is difficult to control arrhythmia, hypertension, or six months had a myocardial infarction attack, or cardiac insufficiency;
  3. Organ transplantation patients need immunosuppressive therapy;
  4. Severe recurrent infections were not controlled or with other serious concomitant diseases;
  5. Patients got other primary malignant tumors (except curable skin basal cell carcinoma and cervical cancer in situ) except gastric cancer within 5 years;
  6. Psychiatric disease which require treatment;
  7. Have the history of organ transplantation;
  8. Within 6 months before study starts and in the process of this study, patients participate in other clinical researches.
  9. Advanced gastric cancer with omentum invasion
  10. Patients can't treated with XELOX after surgery;
  11. Macroscopic types : Borrmann IV;
  12. Tumor invasion of adjacent organ (T4b) or with distant metastasis（M1）;
  13. Tumor invasion the greater curvature invasion.

Sites / Locations

  • Tianjin Medical University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

D2 radical gastrectomy with partial omentectomy

D2 radical gastrectomy with total omentectom

Outcomes

Primary Outcome Measures

3 years relapse-free survival
Relapse-free survival l (RFS) was defined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death.

Secondary Outcome Measures

5 years overall survival
Overall survival (OS) was defined as the length of time from the date of randomization to the date of death of various reasons.

Full Information

First Posted
September 15, 2019
Last Updated
September 26, 2019
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04108494
Brief Title
A Trial of Total Versus Partial Omentectomy for Advanced Gastric Cancer in Gastrectomy
Acronym
TOP1
Official Title
A Single-center, Randomized, Controlled Trial to Evaluate Total Versus Partial Omentectomy for Advanced Gastric Cancer in Radical Gastrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main purpose of this study is to evaluate the impact of omentectomy for advanced gastric cancer on patient survival.
Detailed Description
Surgical resection is the mainstay of treatment for gastric cancer. The extent of surgical resection includes total or subtotal gastrectomy, D2 lymphadenectomy, and prophylactic or therapeutic resection of the surrounding organs or tissues (e.g., omentum, peritoneum, etc). However, the oncologic importance of omentectomy during gastrectomy remains unclear. The European guidelines do not give any advice regarding omentectomy, whereas the most recent American guidelines advise to resect both the greater and lesser omentum. Alternatively, the Japanese gastric cancer treatment guidelines recommends preservation of the greater omentum at >3 cm from the gastroepiploic arcade for patients with T1-T2 tumors and total omentectomy for patients with T3-T4 tumors. In order to evaluate the impact of omentectomy for advanced gastric cancer on patient survival, we designed this trial. Patients who received curative gastrectomy were divided into two groups based on whether they underwent omentectomy. The primary endpoint is the 3-year relapse-free survival rate and the secondary endpoints are 5-year overall survival, and postoperative morbidity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric Cancer, Omentectomy, Prognosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
418 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
D2 radical gastrectomy with partial omentectomy
Arm Title
Control group
Arm Type
No Intervention
Arm Description
D2 radical gastrectomy with total omentectom
Intervention Type
Procedure
Intervention Name(s)
Type of omentectomy
Intervention Description
Partial omentectomy with preservation of the greater omentum at >3 cm from the gastroepiploic arcade.Control group with total omentectomy.
Primary Outcome Measure Information:
Title
3 years relapse-free survival
Description
Relapse-free survival l (RFS) was defined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
5 years overall survival
Description
Overall survival (OS) was defined as the length of time from the date of randomization to the date of death of various reasons.
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
The volume of intraoperative blood loss
Description
The volume of intraoperative blood loss (IBL) was defined as the total from suction and the weight of gauze sponges at the conclusion of the operation. The Blood loss volume is recorded in milliliters.
Time Frame
1 week
Title
The length of the operation
Description
The length of the operation was defined as the time from first skin incision to wound closure. The length of the operation is recorded in minutes.
Time Frame
1 week
Title
Postoperative hospital stay
Description
Postoperative hospital stay was defined as the time from the date of operation to the date of discharge. The postoperative hospital stay is recorded in days.
Time Frame
3 months
Title
Postoperative morbidity
Description
Postoperative morbidity was defined as the incidence rate of the postoperative complication. The postoperative morbidity were examined within 30 days after surgery. Postoperative morbidity was graded with use of the modified Clavien-Dindo classification of surgical complications.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Had been treated with Radical resection (D2, R0) of gastric cancer (Lymph node≥16); Physical condition and organ function allows to tolerable abdominal surgery; Willing and able to comply with the program during the study period; Written informed consent provided; ≥ 18 and ≤ 70 years of age; preoperative gastric cancer patients with pathologically confirmed; With more than a 6-month life expectancy; No other serious concomitant diseases; Sufficient organ functions; No previous history of chemotherapy or radiotherapy; All patients accept 8 cycles XELOX chemotherapy regimen; Clinical stage: T2-4aN0-+M0; Macroscopic types :Borrmann I-III; Not greater curvature tumor; No previous surgery for any abdominal disease, except an appendectomy for appendicitis, a laparoscopic cholecystectomy for gallbladder stones; No previous history of peritonitis, pancreatitis; Karnofsky performance status (KPS)>60; Eastern Cooperative Oncology Group Performance Status (ECOG): 0-1. Exclusion Criteria: Pregnancy or breast feeding; Patients with Serious liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, hypertension and other chronic systemic diseases, heart disease with Clinical symptoms, such as congestive heart failure, coronary heart disease symptoms, drug is difficult to control arrhythmia, hypertension, or six months had a myocardial infarction attack, or cardiac insufficiency; Organ transplantation patients need immunosuppressive therapy; Severe recurrent infections were not controlled or with other serious concomitant diseases; Patients got other primary malignant tumors (except curable skin basal cell carcinoma and cervical cancer in situ) except gastric cancer within 5 years; Psychiatric disease which require treatment; Have the history of organ transplantation; Within 6 months before study starts and in the process of this study, patients participate in other clinical researches. Advanced gastric cancer with omentum invasion Patients can't treated with XELOX after surgery; Macroscopic types : Borrmann IV; Tumor invasion of adjacent organ (T4b) or with distant metastasis（M1）; Tumor invasion the greater curvature invasion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Han Liang, Master
Phone
+86 022 23340123
Ext
1061
Email
tjlianghan@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bin Ke, Doctor
Phone
+86 13622036809
Email
binke@tmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han Liang, Master
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tianjin Medical University Cancer Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han Liang, Master
Phone
+86 022 23340123
Ext
1061
Email
tjlianghan@126.com
First Name & Middle Initial & Last Name & Degree
Bin Ke, Doctor
Phone
+86 13622036809
Email
binke@tmu.edu.cn

12. IPD Sharing Statement

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A Trial of Total Versus Partial Omentectomy for Advanced Gastric Cancer in Gastrectomy

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