Esophageal CancerPhase 2NCT01349517
Health-related Quality of Life of Patients With Esophageal Cancer After Surgery
A Phase 2 study testing MIE, Three-incision thoracotomy and Ivor-Lewis esophagectomy in people with Esophageal Cancer, run by Fudan University at 1 site in China.
Trial summary
The purpose of this multi-center prospective cohort study is to study the health-related quality of life (HRQL) together with other outcomes of patients with esophageal cancer after surgery in China. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- MIE, Three-incision thoracotomy and Ivor-Lewis esophagectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- May 2011to Dec 2016
- Phase
- Phase 2
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical stage I/II esophageal cancer
- Normal blood test of basic metabolism panel
- Pulmonary function: FEV1 > 1.2L, FEV1% > 50%, DLCO > 50%
- Heart function: NY grade I and grade II
Who cannot join
- Mental disorders
- Combination with other cancers
- With a previous history of thoracic or ventral surgery
Trial locations and contacts
1 site in 1 country.
China1 site
Zhong Shan Hospital, Fu Dan University
Shanghai, Shanghai Municipality, 200032
Lijie Tan, MD, 86-021-64041990 ext. 2914, tan.lijie@zs-hospital.sh.cn
About this study
Official title: Health-related Quality of Life of Patients With Esophageal Cancer After Surgery in China: A Prospective Cohort Study From Multi-center
The purpose of this multi-center prospective cohort study is to study the health-related quality of life (HRQL) together with other outcomes of patients with esophageal cancer after surgery in China.
Read the detailed description
- To study the influence of health-related quality of life of patients with esophageal cancer before and after surgery.
- To compare the impact of different procedures on the the health-related quality of life of patients with esophageal cancer.
- To compare morbidities and oncological results(3,5- year survival) from different procedures.
- Conditions
- Esophageal Cancer
- Being tested
- MIE, Three-incision thoracotomy, Ivor-Lewis esophagectomy, Sweet esophagectomy
- Keywords
- health-related quality of life(HRQL), Esophageal Cancer
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIEProcedure or surgery
Also called esophagectomy
The patients in this group would perform minimal invasive three-incision subtotal esophagectomy (thoracoscopic and/or laparoscopic)
Three-incision thoracotomyProcedure or surgery
Also called esophagectomy
The patients in this group would perform three-incision subtotal esophagectomy (thoracotomy and laparotomy)
Ivor-Lewis esophagectomyProcedure or surgery
Also called esophagectomy
The patients in this group would underwent Ivor-Lewis esophagectomy
Sweet esophagectomyProcedure or surgery
Also called esophagectomy
The patients in this group would underwent Sweet esophagectomy.
| Study group | Role | What they receive |
|---|---|---|
| MIE Group | Other | The patients in this group would perform minimal invasive three-incision subtotal esophagectomy (thoracoscopic and/or laparoscopic) Receives: Procedure: MIE |
| Three-incision esophagectomy group | Other | The patients in this group would perform three-incision subtotal esophagectomy (thoracotomy and laparotomy) Receives: Procedure: Three-incision thoracotomy |
| Ivor-Lewis esophagectomy group | Other | The patients in this group would underwent Ivor-Lewis esophagectomy Receives: Procedure: Ivor-Lewis esophagectomy |
| Sweet esophagectomy group | Other | The patients in this group would underwent Sweet esophagectomy. Receives: Procedure: Sweet esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life
Health related quality of life from the different precedure groups (assessed by EORTC QLQ C-30 and OES-18)
Measured: postoperative 2 year
Secondary outcomes (1)
Morbidity Mortality Survival rate
- Perioperative morbidity and mortality from the different precedure groups.
- 3-and 5-year survival rate between the groups.
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 posted6 May 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Hospital of Jilin University, Fujian Medical University Union Hospital, Shanxi Province Cancer Hospital, Wuxi People's Hospital, Linyi People's Hospital
- Investigators
- Lijie Tan, MD, Study chair, Zhongshan Hospital, Fudan University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349517
- Sponsor's protocol ID
- ZSchest2011001
- Status last verified
- Jan 2011
- First submitted
- 3 May 2011
- Last updated
- 11 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-related Quality of Life of Patients With Esophageal Cancer After Surgery in China: A Prospective Cohort Study From Multi-center
- ClinicalTrials.gov ID
- NCT01349517
- Acronym / sponsor ID
- ZSchest2011001
- Conditions
- Esophageal Cancer
- Keywords
- health-related quality of life(HRQL), Esophageal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- The First Hospital of Jilin University, Fujian Medical University Union Hospital, Shanxi Province Cancer Hospital, Wuxi People's Hospital, Linyi People's Hospital
- Study start
- May 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 6 May 2011 (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 multi-center prospective cohort study is to study the health-related quality of life (HRQL) together with other outcomes of patients with esophageal cancer after surgery in China.
Detailed description
- To study the influence of health-related quality of life of patients with esophageal cancer before and after surgery.
- To compare the impact of different procedures on the the health-related quality of life of patients with esophageal cancer.
- To compare morbidities and oncological results(3,5- year survival) from different procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MIE Group | Other | Procedure: MIEThe patients in this group would perform minimal invasive three-incision subtotal esophagectomy (thoracoscopic and/or laparoscopic) |
| Three-incision esophagectomy group | Other | Procedure: Three-incision thoracotomyThe patients in this group would perform three-incision subtotal esophagectomy (thoracotomy and laparotomy) |
| Ivor-Lewis esophagectomy group | Other | Procedure: Ivor-Lewis esophagectomyThe patients in this group would underwent Ivor-Lewis esophagectomy |
| Sweet esophagectomy group | Other | Procedure: Sweet esophagectomyThe patients in this group would underwent Sweet esophagectomy. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical stage I/II esophageal cancer
- Normal blood test of basic metabolism panel
- Pulmonary function: FEV1 > 1.2L, FEV1% > 50%, DLCO > 50%
- Heart function: NY grade I and grade II
Key exclusion criteria (3 listed)
- Mental disorders
- Combination with other cancers
- With a previous history of thoracic or ventral surgery
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 |
|---|---|---|
| MIEAlso: esophagectomyThe patients in this group would perform minimal invasive three-incision subtotal esophagectomy (thoracoscopic and/or laparoscopic) | Procedure or surgery | MIE Group |
| Three-incision thoracotomyAlso: esophagectomyThe patients in this group would perform three-incision subtotal esophagectomy (thoracotomy and laparotomy) | Procedure or surgery | Three-incision esophagectomy group |
| Ivor-Lewis esophagectomyAlso: esophagectomyThe patients in this group would underwent Ivor-Lewis esophagectomy | Procedure or surgery | Ivor-Lewis esophagectomy group |
| Sweet esophagectomyAlso: esophagectomyThe patients in this group would underwent Sweet esophagectomy. | Procedure or surgery | Sweet esophagectomy group |
Primary outcome
Health related quality of life
Time frame: postoperative 2 year
Health related quality of life from the different precedure groups (assessed by EORTC QLQ C-30 and OES-18)
1 secondary outcome
Morbidity Mortality Survival rate
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 11 Nov 2011.
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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.
Lijie Tan, MD study chair
Zhongshan Hospital, Fudan University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MIE, Three-incision thoracotomy and Ivor-Lewis esophagectomy in people with Esophageal Cancer, 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 4 inclusion and 3 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 11 Nov 2011. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Tan Lijie, MD (86-021-64041990 ext. 2914, tan.lijie@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life (time frame: postoperative 2 year). 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 11 Nov 2011.