Esophageal NeoplasmsNCT01807936
Esophagectomy:Three-field Versus Two-field Lymphadenectomy (ECTOP-2002)
A study testing Lymphadenectomy in people with Esophageal Neoplasms, run by Fudan University at 1 site in China.
Trial summary
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-2002. Esophageal carcinoma is an aggressive disease with a poor prognosis. Surgical resection with radical lymphadenectomy remains the basic method of management of this malignancy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Neoplasms
- What is being tested?
- Lymphadenectomy
- 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
- 20 Mar 2013to Nov 2019
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically proven squamous cell esophageal cancer
- Patients with cT1-T3/N0-N1 mid or distal third (inferior to carina and 3cm superior to cardia ) operable esophageal lesion. Staging investigations including esophagogastroscopy, chest and abdominal CT scan, barium swallow and selective endoscopic ultrasonography showing no evidence of invading adjacent structure such as spine, bronchus, pericardium , descending aorta and without enlargement cervical and celiac nodes (diameter of short axis greater than 1.5cm) measured at CT scans.
- Karnofsky performance status greater than or equal to 80%
- Pulmonary and cardiac function must be acceptable for surgery according to institutional standards.
- Acceptable hepatic, renal and bone marrow function
Who cannot join
- Patients with low performance status(Karnofsky score <80%)
- Past history of malignancy
- Stage investigations indicating unresectable advanced disease(T4 or M1a,M1b)
- Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment
- Patients medically unfit for surgical resection
- Patients with pulmonary reserve inadequate to undergo thoracotomy and extensive mediastinal lymphadenectomy.
Show all 14Show fewer
- Patients with a significant history of unstable cardiovascular disease that in the opinion of the treating physician should preclude the patient from protocol treatment.
- Uncontrolled diabetes mellitus or uncontrolled infection, including HIV or interstitial pneumonia or interstitial fibrosis.
- Significant psychiatric illness that would interfere with patient compliance
- Patients with severe hepatic cirrhosis or with serious renal disease unacceptable for surgery
- Patients considered of salvage surgery after definitive chemoradiotherapy
- Patients after neoadjuvant chemoradiotherapy
- Patients above the age of 75 years
- Patients unreliable for follow up
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Esophagectomy: Three-field Lymphadenectomy Versus. Two-field Lymphadenectomy for Thoracic Middle and Lower Esophageal Cancer
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-2002. Esophageal carcinoma is an aggressive disease with a poor prognosis. Surgical resection with radical lymphadenectomy remains the basic method of management of this malignancy. Lymph node metastasis is one of the most important factors in predicting the prognosis of patients with esophageal carcinoma, but the extent of lymph node dissection is still in debate, and there is no statistical evidence based on large scale prospective randomized trials with regard to the issue that which is the optimal extent of lymphadenectomy for esophageal cancer. The purpose of this study is to test two different extents of lymphadenectomy (Cervical-thoracic-upper abdominal three-field lymphadenectomy and Thoracic-upper abdominal two -field lymphadenectomy) in middle or lower third intrathoracic esophageal cancer. This research is being done to see whether one extent of lymphadenectomy is superior than the other with better long-term outcome and acceptable postoperative short-term outcome or not.
Read the detailed description
Background :
Esophageal carcinoma is an aggressive disease with a poor prognosis. Surgical resection with radical lymphadenectomy remains the basic method of management of this malignancy. The international Society for Diseases of the Esophagus has classified the extent of lymphadenectomy as standard, extended, total, and three-field lymphadenectomy. However, lymph node metastases can be present as regional metastasis, skip metastasis and distant metastasis, the optimal extent of lymphadenectomy remains controversial by now. Three-filed lymphadenectomy was criticized for higher surgical risks, but have the merits of removing all potential positive nodes and reducing the local recurrence. The purpose of this study is to conduct a large scale prospective randomized Phase Ⅲ clinical trial to test that based on the long-term outcomes(overall survival and disease free survival )and postoperative short-term outcomes(mortality, morbidity),whether one extent of lymphadenectomy is superior than the other approach or not.
Objectives:
- To compare overall survival after three-field lymphadenectomy and two-field lymphadenectomy
- To compare locoregional recurrence, disease free survival after three-field lymphadenectomy and two-field lymphadenectomy
- To compare postoperative morbidity and mortality in the two groups
Design: Prospective randomized controlled Setting: Fudan University Cancer Center, Shanghai, China. Patients and methods : All patients with biopsy proven carcinoma of the middle or lower third of the esophagus presenting to our hospital will be considered for the study.
Staging investigations will be standard and will include
- Computed Tomography (CT) scans in all patients
- Esophagogastroscopy
- Barium swallow
- Endoscopic Ultrasonography (EUS) wherever possible
- PET-CT scan wherever possible
Randomization:
Randomization, by the sealed envelope method, took place on the morning of planed surgery day.
All surgeries will be performed under general anesthesia with epidural analgesia. The surgery will be either performed by or under the direct supervision of consultant thoracic surgeons with experience in esophageal surgery. Operative time, blood loss, blood product replacement and all intraoperative details will be recorded in the proforma. Patients will be shifted postoperatively to the intensive care unit (ICU) for observation and subsequently to the recovery or high dependency ward once stabilized. Postoperative details including period of postoperative ventilation, hemorrhage, pulmonary and cardiac complications, arrhythmias, thoracic duct leak, anastomotic leak, wound infection and recurrent laryngeal nerve paresis or palsy will be recorded. Postoperative mortality will be defined as 30-day mortality plus death before discharge after surgery. The total duration of ICU stay and hospital stay will also be recorded.
Follow up:
Patients will be followed up three monthly for the first two years and six monthly for the third to fifth years and annually thereafter. A detailed history and clinical examination and CT scan, barium swallow and ultrasound will be done routinely on every follow up.
Data management: All collected data will be entered into a statistical software package for subsequent analysis
Main research variables:
Primary end point: Overall survival
Secondary endpoints:
- Disease free survival in the two arms
- Locoregional recurrence
- Postoperative morbidity and mortality
- Conditions
- Esophageal Neoplasms
- Being tested
- Lymphadenectomy
- Keywords
- Esophageal Neoplasms, lymphadenectomy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LymphadenectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Three-field lymphadenectomy | Experimental | Cervical-thoracic-upper abdominal three-field lymphadenectomy Receives: Procedure: Lymphadenectomy |
| Two -field lymphadenectomy | No intervention | Thoracic-upper abdominal two -field lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Participants will be seen at regular interval of 3 months the first year and every 6 months until death or the 3rd year.
Measured: 3 years.
Secondary outcomes (1)
Disease free survival
Participants will be seen at regular interval of 3 months the first year and every 6 months until recurrence or the 3rd year.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study start20 Mar 2013
- Primary completion1 Nov 2016
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal NeoplasmsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiquan Chen, Fudan University
- Investigators
- Haiquan Chen, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807936
- Sponsor's protocol ID
- 2VS3E
- Status last verified
- Jul 2023
- First submitted
- 6 Mar 2013
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Li B, Hu H, Zhang Y, Zhang J, Miao L, Ma L, Luo X, Zhang Y, Ye T, Li H, Li Y, Shen L, Zhao K, Fan M, Zhu Z, Wang J, Xu J, Deng Y, Lu Q, Li H, Zhang Y, Pan Y, Liu S, Hu H, Shao L, Sun Y, Xiang J, Chen H. Three-field versus two-field lymphadenectomy in transthoracic oesophagectomy for oesophageal squamous cell carcinoma: short-term outcomes of a randomized clinical trial. Br J Surg. 2020 May;107(6):647-654. doi: 10.1002/bjs.11497. Epub 2020 Feb 28.
PubMed 32108326
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophagectomy: Three-field Lymphadenectomy Versus. Two-field Lymphadenectomy for Thoracic Middle and Lower Esophageal Cancer
- ClinicalTrials.gov ID
- NCT01807936
- Acronym / sponsor ID
- 2VS3E
- Conditions
- Esophageal Neoplasms
- Keywords
- Esophageal Neoplasms, lymphadenectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 20 Mar 2013 (actual)
- Primary completion
- 1 Nov 2016 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 8 Mar 2013 (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.
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-2002. Esophageal carcinoma is an aggressive disease with a poor prognosis. Surgical resection with radical lymphadenectomy remains the basic method of management of this malignancy. Lymph node metastasis is one of the most important factors in predicting the prognosis of patients with esophageal carcinoma, but the extent of lymph node dissection is still in debate, and there is no statistical evidence based on large scale prospective randomized trials with regard to the issue that which is the optimal extent of lymphadenectomy for esophageal cancer. The purpose of this study is to test two different extents of lymphadenectomy (Cervical-thoracic-upper abdominal three-field lymphadenectomy and Thoracic-upper abdominal two -field lymphadenectomy) in middle or lower third intrathoracic esophageal cancer. This research is being done to see whether one extent of lymphadenectomy is superior than the other with better long-term outcome and acceptable postoperative short-term outcome or not.
Detailed description
Background :
Esophageal carcinoma is an aggressive disease with a poor prognosis. Surgical resection with radical lymphadenectomy remains the basic method of management of this malignancy. The international Society for Diseases of the Esophagus has classified the extent of lymphadenectomy as standard, extended, total, and three-field lymphadenectomy. However, lymph node metastases can be present as regional metastasis, skip metastasis and distant metastasis, the optimal extent of lymphadenectomy remains controversial by now. Three-filed lymphadenectomy was criticized for higher surgical risks, but have the merits of removing all potential positive nodes and reducing the local recurrence. The purpose of this study is to conduct a large scale prospective randomized Phase Ⅲ clinical trial to test that based on the long-term outcomes(overall survival and disease free survival )and postoperative short-term outcomes(mortality, morbidity),whether one extent of lymphadenectomy is superior than the other approach or not.
Objectives:
- To compare overall survival after three-field lymphadenectomy and two-field lymphadenectomy
- To compare locoregional recurrence, disease free survival after three-field lymphadenectomy and two-field lymphadenectomy
- To compare postoperative morbidity and mortality in the two groups
Design: Prospective randomized controlled Setting: Fudan University Cancer Center, Shanghai, China. Patients and methods : All patients with biopsy proven carcinoma of the middle or lower third of the esophagus presenting to our hospital will be considered for the study.
Staging investigations will be standard and will include
- Computed Tomography (CT) scans in all patients
- Esophagogastroscopy
- Barium swallow
- Endoscopic Ultrasonography (EUS) wherever possible
- PET-CT scan wherever possible
Randomization:
Randomization, by the sealed envelope method, took place on the morning of planed surgery day.
All surgeries will be performed under general anesthesia with epidural analgesia. The surgery will be either performed by or under the direct supervision of consultant thoracic surgeons with experience in esophageal surgery. Operative time, blood loss, blood product replacement and all intraoperative details will be recorded in the proforma. Patients will be shifted postoperatively to the intensive care unit (ICU) for observation and subsequently to the recovery or high dependency ward once stabilized. Postoperative details including period of postoperative ventilation, hemorrhage, pulmonary and cardiac complications, arrhythmias, thoracic duct leak, anastomotic leak, wound infection and recurrent laryngeal nerve paresis or palsy will be recorded. Postoperative mortality will be defined as 30-day mortality plus death before discharge after surgery. The total duration of ICU stay and hospital stay will also be recorded.
Follow up:
Patients will be followed up three monthly for the first two years and six monthly for the third to fifth years and annually thereafter. A detailed history and clinical examination and CT scan, barium swallow and ultrasound will be done routinely on every follow up.
Data management: All collected data will be entered into a statistical software package for subsequent analysis
Main research variables:
Primary end point: Overall survival
Secondary endpoints:
- Disease free survival in the two arms
- Locoregional recurrence
- Postoperative morbidity and mortality
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Three-field lymphadenectomy | Experimental | Procedure: LymphadenectomyCervical-thoracic-upper abdominal three-field lymphadenectomy |
| Two -field lymphadenectomy | No intervention | –Thoracic-upper abdominal two -field lymphadenectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with histologically proven squamous cell esophageal cancer
- Patients with cT1-T3/N0-N1 mid or distal third (inferior to carina and 3cm superior to cardia ) operable esophageal lesion. Staging investigations including esophagogastroscopy, chest and abdominal CT scan, barium swallow and selective endoscopic ultrasonography showing no evidence of invading adjacent structure such as spine, bronchus, pericardium , descending aorta and without enlargement cervical and celiac nodes (diameter of short axis greater than 1.5cm) measured at CT scans.
- Karnofsky performance status greater than or equal to 80%
- Pulmonary and cardiac function must be acceptable for surgery according to institutional standards.
- Acceptable hepatic, renal and bone marrow function
Key exclusion criteria (14 listed)
- Patients with low performance status(Karnofsky score <80%)
- Past history of malignancy
- Stage investigations indicating unresectable advanced disease(T4 or M1a,M1b)
- Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment
- Patients medically unfit for surgical resection
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 |
|---|---|---|
| Lymphadenectomy | Procedure or surgery | Three-field lymphadenectomy |
Primary outcome
Overall survival
Time frame: 3 years.
Participants will be seen at regular interval of 3 months the first year and every 6 months until death or the 3rd year.
1 secondary outcome
Disease free survival
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Derived from this study: PubMed 32108326Li B, Hu H, Zhang Y, Zhang J, Miao L, Ma L, Luo X, Zhang Y, Ye T, Li H, Li Y, Shen L, Zhao K, Fan M, Zhu Z, Wang J, Xu J, Deng Y, Lu Q, Li H, Zhang Y, Pan Y, Liu S, Hu H, Shao L, Sun Y, Xiang J, Chen H. Three-field versus two-field lymphadenectomy in transthoracic oesophagectomy for oesophageal squamous cell carcinoma: short-term outcomes of a randomized clinical trial. Br J Surg. 2020 May;107(6):647-654. doi: 10.1002/bjs.11497. Epub 2020 Feb 28.
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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.
Haiquan Chen, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphadenectomy in people with Esophageal Neoplasms, 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 5 inclusion and 14 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: finished, as of the sponsor's last update on 20 Jul 2023. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01807936, which also lists 1 linked publication.
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 20 Jul 2023.