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A Phase III Study Comparing Total and Partial Omentectomy for Patients With Advanced Gastric Cancer

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, Prognosis, Omentectomy

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: T3-4aN0-+M0; 11 . Macroscopic types :Borrmann I-III;

12. Not greater curvature tumor; with distal or total gastrectomy; 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:

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

  • Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group/D2 radical gastrectomy with partial omentectomy

Control group/D2 radical gastrectomy with total omentectom

Arm Description

Partial omentectomy with preservation of the greater omentum at >3 cm from the gastroepiploic arcade.

Control group with total omentectomy

Outcomes

Primary Outcome Measures

Disease Free Survival(DFS)
Disease Free Survivalof the Participants

Secondary Outcome Measures

Overall Survival(OS)
Overall Survival of the Participants

Full Information

First Posted
April 11, 2021
Last Updated
May 5, 2021
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
Peking University Cancer Hospital & Institute, Shanghai Zhongshan Hospital, Fujian Cancer Hospital, Fujian Medical University Union Hospital, First Affiliated Hospital of Guangxi Medical University, Harbin Medical University, Hebei Medical University Fourth Hospital, Wuhan Union Hospital, China, The First Affiliated Hospital with Nanjing Medical University, Changzhi People's Hospital, Xijing Hospital of Air Force Military Medical University, First Affiliated Hospital of Kunming Medical University, LanZhou University, Liaoning Tumor Hospital & Institute, The First Affiliated Hospital of Nanchang University, Shandong Provincial Hospital, West China Hospital, Xinjiang Medical University Cancer Hospital, Zhejiang Cancer Hospital, Chinese PLA General Hospital, Sun Yat-sen University Cancer Hosptial, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04843215
Brief Title
A Phase III Study Comparing Total and Partial Omentectomy for Patients With Advanced Gastric Cancer
Official Title
A Phase III, Multicenter, Prospective, Randomized, Controlled Clinical Trial Comparing Total and Partial Omentectomy for Patients With Advanced Gastric Cancer (TOP-GC)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
Peking University Cancer Hospital & Institute, Shanghai Zhongshan Hospital, Fujian Cancer Hospital, Fujian Medical University Union Hospital, First Affiliated Hospital of Guangxi Medical University, Harbin Medical University, Hebei Medical University Fourth Hospital, Wuhan Union Hospital, China, The First Affiliated Hospital with Nanjing Medical University, Changzhi People's Hospital, Xijing Hospital of Air Force Military Medical University, First Affiliated Hospital of Kunming Medical University, LanZhou University, Liaoning Tumor Hospital & Institute, The First Affiliated Hospital of Nanchang University, Shandong Provincial Hospital, West China Hospital, Xinjiang Medical University Cancer Hospital, Zhejiang Cancer Hospital, Chinese PLA General Hospital, Sun Yat-sen University Cancer Hosptial, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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
This is a phase III, multicenter, prospective, randomized, controlled clinical trial to evaluate the impact of omentectomy for advanced gastric cancer on patient survival.
Detailed Description
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 purpose of this study is to prove the non-inferiority of omentum preservation compared with omentectomy in patients with T3-T4a gastric cancer.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Experimental group/D2 radical gastrectomy with partial omentectomy
Arm Type
Experimental
Arm Description
Partial omentectomy with preservation of the greater omentum at >3 cm from the gastroepiploic arcade.
Arm Title
Control group/D2 radical gastrectomy with total omentectom
Arm Type
No Intervention
Arm Description
Control group with total omentectomy
Intervention Type
Procedure
Intervention Name(s)
Type of omentectomy
Intervention Description
Experimental group D2 radical gastrectomy with partial omentectomy. 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
Disease Free Survival(DFS)
Description
Disease Free Survivalof the Participants
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall Survival(OS)
Description
Overall Survival of the Participants
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
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: T3-4aN0-+M0; 11 . Macroscopic types :Borrmann I-III; 12. Not greater curvature tumor; with distal or total gastrectomy; 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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Han Liang, Master
Phone
+86 022 233401 23
Ext
1061
Email
tjlianghan@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bik Ke, Doctor
Phone
+86 022 23340123
Ext
1061
Email
binke@tmu.edu.cn
Facility Information:
Facility Name
Department of Gastrointestinal Medical Oncology, 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
Liang Han
Phone
086-022-23340123
Ext
1061
Email
tjlianghan@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Phase III Study Comparing Total and Partial Omentectomy for Patients With Advanced Gastric Cancer

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