Adenocarcinoma of Esophagogastric Junction.Phase 3GCQOL01NCT01697917
Impact on Quality of Life in Patients Undergoing Total Gastrectomy or Proximal Gastrectomy for Adenocarcinoma of Esophagogastric Junction
A Phase 3 study testing Total Gastrectomy or Proximal Gastrectomy in people with Adenocarcinoma of Esophagogastric Junction., run by Fudan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Adenocarcinoma of Esophagogastric Junction.
- What is being tested?
- Total Gastrectomy or Proximal Gastrectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- May 2012to May 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Ya Nong Wang, MD,PhD, +86-21 64175590 ext. 1208, huahuang@fudan.edu.cn
Hua Huang, MD,PhD, +86-21 64175590 ext. 1205, huahuang@fudan.edu.cn
About this study
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
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.
Read the 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.
- Being tested
- Total Gastrectomy or Proximal Gastrectomy
- Keywords
- Adenocarcinoma of Esophagogastric Junction, Total Gastrectomy, Proximal Gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Gastrectomy or Proximal GastrectomyOther
| Study group | Role | What they receive |
|---|---|---|
| Total Gastrectomy or Proximal Gastrectomy | Other | Not described Receives: Other: Total Gastrectomy or Proximal Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5years
Secondary outcomes (1)
Nutritional status of patients
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2015 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of Esophagogastric Junction.Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanong Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697917
- Sponsor's protocol ID
- 2012-44-562
- Acronym
- GCQOL01
- Status last verified
- Sep 2012
- First submitted
- 29 Sep 2012
- Last updated
- 2 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01697917
- Acronym / sponsor ID
- GCQOL01 / 2012-44-562
- Keywords
- Adenocarcinoma of Esophagogastric Junction, Total Gastrectomy, Proximal Gastrectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Gastrectomy or Proximal Gastrectomy | Other | Other: Total Gastrectomy or Proximal Gastrectomy |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • 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.
Key exclusion criteria (6 listed)
- • AEG SiewertⅠtype patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Gastrectomy or Proximal Gastrectomy | Other | Total Gastrectomy or Proximal Gastrectomy |
Primary outcome
Change in QOL (Quality of Life)
Time frame: 5years
From preoperative following gastrectomy, as measured with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-STO22 questionnaires.
1 secondary outcome
Nutritional status of patients
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Total Gastrectomy or Proximal Gastrectomy in people with Adenocarcinoma of Esophagogastric Junction., run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang Ya Nong, MD, PhD (+86-21 64175590 ext. 1208, huahuang@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in QOL (Quality of Life) (time frame: 5years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2012; AzTrials last refreshed its copy on 8 Nov 2026.