Impact on Quality of Life in Patients Undergoing Total Gastrectomy or Proximal Gastrectomy for Adenocarcinoma of Esophagogastric Junction (GCQOL01)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Yanong Wang, Fudan University
ClinicalTrials.gov Identifier:
NCT01697917
First received: September 29, 2012
Last updated: October 1, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Adenocarcinoma of Esophagogastric Junction.
Other: Total Gastrectomy or Proximal Gastrectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Change in QOL (Quality of Life) [ Time Frame: 5years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 5 years ]

Estimated Enrollment: 140
Study Start Date: May 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Total Gastrectomy or Proximal Gastrectomy Other: Total Gastrectomy or Proximal 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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697917

Contacts
Contact: Wang Ya Nong, MD, PhD +86-21 64175590 ext 1208 huahuang@fudan.edu.cn
Contact: Huang Hua, MD,PhD +86-21 64175590 ext 1205 huahuang@fudan.edu.cn

Locations
China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Ya Nong Wang, MD,PhD    +86-21 64175590 ext 1208    huahuang@fudan.edu.cn   
Contact: Hua Huang, MD,PhD    +86-21 64175590 ext 1205    huahuang@fudan.edu.cn   
Sponsors and Collaborators
Fudan University
  More Information

No publications provided

Responsible Party: Yanong Wang, Director of Department of Abdominal Surgery, Fudan University
ClinicalTrials.gov Identifier: NCT01697917     History of Changes
Other Study ID Numbers: 2012-44-562
Study First Received: September 29, 2012
Last Updated: October 1, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Fudan University:
Adenocarcinoma of Esophagogastric Junction
Total Gastrectomy
Proximal Gastrectomy

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on September 14, 2014