Back to resultsImpact on Quality of Life in Patients Undergoing Total Gastrectomy or Proximal Gastrectomy for Adenocarcinoma of Esophagogastric Junction (GCQOL01)
Primary Purpose
Adenocarcinoma of Esophagogastric Junction.
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Total Gastrectomy or Proximal Gastrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Adenocarcinoma of Esophagogastric Junction. focused on measuring Adenocarcinoma of Esophagogastric Junction, Total Gastrectomy, Proximal Gastrectomy
Eligibility Criteria
Inclusion Criteria:
• Pathologically confirmed gastric malignant tumor at FUSCC (biopsy may be performed at other institutions but slides must be confirmed at FUSCC, as is routine care at our institution), and the patients be assessed can achieve R0 radical dissection through total gastrectomy or proximal gastrectomy by three specialists.
- Patients 20-75 years old
- Normal organ function, able to tolerate surgery, no clear contraindication for surgery
- No evidence of metastases of adjacent organs
- be able to provide follow-up over 2 years
- No specific treatment for gastric cancer before surgery
- In line with the Declaration of Helsinki and the requirements of the hospital ethics committee.
- The subjects were able to understand and comply with the trial protocol, and signed informed consent.
Exclusion Criteria:
• AEG SiewertⅠtype patients
- Synchronous or metachronous (less than five years) and patients with other malignancies.
- Cirrhosis and portal hypertension
- Associated with blood diseases
- Serious heart/ lung and kidney dysfunction or with metabolic diseases such as diabetes, hyperthyroidism.
- Suffering from a serious neurological disease or psychological diseases affecting the life.
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Total Gastrectomy or Proximal Gastrectomy
Arm Description
Outcomes
Primary Outcome Measures
Change in QOL (Quality of Life)
From preoperative following gastrectomy, as measured with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-STO22 questionnaires.
Secondary Outcome Measures
Nutritional status of patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01697917
Brief Title
Impact on Quality of Life in Patients Undergoing Total Gastrectomy or Proximal Gastrectomy for Adenocarcinoma of Esophagogastric Junction
Acronym
GCQOL01
Official Title
A Pilot Randomized Controlled Trial Examining the Differences of Quality of Life of Patients Undergoing Total Gastrectomy or Proximal Gastrectomy for Adenocarcinoma of Esophagogastric Junction
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
May 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to find out more about differences of the quality of life in patients undergoing total gastrectomy or proximal gastrectomy for adenocarcinoma of esophagogastric junction. To find a better reconstruction for patients who received total gastrectomy.
Detailed Description
Overall, the incidence of stomach cancer worldwide is declining with geographical variation. However, an increase in the incidence rate of adenocarcinoma of esophagogastric junction, called cardia or AEG has been observed in recent years. AEG may represent a specific histopathological and biologic entity. In the treatment AEG there is argument over whether proximal gastractomy(PG) or total gastractomy (TG) should be done. The quality of life (QOL) of the patients following TG or PG arouses people's attention. The purpose of this study was to evaluate differences of the quality of life in patients undergoing total gastrectomy or proximal gastrectomy for adenocarcinoma of esophagogastric junction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of Esophagogastric Junction.
Keywords
Adenocarcinoma of Esophagogastric Junction, Total Gastrectomy, Proximal Gastrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Total Gastrectomy or Proximal Gastrectomy
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Total Gastrectomy or Proximal Gastrectomy
Primary Outcome Measure Information:
Title
Change in QOL (Quality of Life)
Description
From preoperative following gastrectomy, as measured with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-STO22 questionnaires.
Time Frame
5years
Secondary Outcome Measure Information:
Title
Nutritional status of patients
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Pathologically confirmed gastric malignant tumor at FUSCC (biopsy may be performed at other institutions but slides must be confirmed at FUSCC, as is routine care at our institution), and the patients be assessed can achieve R0 radical dissection through total gastrectomy or proximal gastrectomy by three specialists.
Patients 20-75 years old
Normal organ function, able to tolerate surgery, no clear contraindication for surgery
No evidence of metastases of adjacent organs
be able to provide follow-up over 2 years
No specific treatment for gastric cancer before surgery
In line with the Declaration of Helsinki and the requirements of the hospital ethics committee.
The subjects were able to understand and comply with the trial protocol, and signed informed consent.
Exclusion Criteria:
• AEG SiewertⅠtype patients
Synchronous or metachronous (less than five years) and patients with other malignancies.
Cirrhosis and portal hypertension
Associated with blood diseases
Serious heart/ lung and kidney dysfunction or with metabolic diseases such as diabetes, hyperthyroidism.
Suffering from a serious neurological disease or psychological diseases affecting the life.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Ya Nong, MD, PhD
Phone
+86-21 64175590
Ext
1208
Email
huahuang@fudan.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Huang Hua, MD,PhD
Phone
+86-21 64175590
Ext
1205
Email
huahuang@fudan.edu.cn
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ya Nong Wang, MD,PhD
Phone
+86-21 64175590
Ext
1208
Email
huahuang@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Hua Huang, MD,PhD
Phone
+86-21 64175590
Ext
1205
Email
huahuang@fudan.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Impact on Quality of Life in Patients Undergoing Total Gastrectomy or Proximal Gastrectomy for Adenocarcinoma of Esophagogastric Junction
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