Impact on Quality of Life in Patients Undergoing Total Gastrectomy or Proximal Gastrectomy for Adenocarcinoma of Esophagogastric Junction

Adenocarcinoma of Esophagogastric Junction. Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01697917
• Other study ID #: 2012-44-562
• Status: Recruiting
• Phase: Phase 3
• First received: September 29, 2012
• Last updated: October 1, 2012
• Start date: May 2012
• Est. completion date: May 2017

Study information

• Verified date: September 2012
• Source: Fudan University
• Contact: Wang Ya Nong, MD, PhD
• Phone: +86-21 64175590
• Email: huahuang[@]fudan.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: May 2017
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Siewert?type 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Esophagogastric Junction.

Intervention

Other:
• Total Gastrectomy or Proximal Gastrectomy

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5years	No
Secondary	Nutritional status of patients		5 years