Esophageal NeoplasmsPhase 3NCT00760604
A Phase III Study of En Bloc Versus Non-En Bloc Esophagectomy in Esophageal Cancer
A Phase 3 study testing Esophagectomy in people with Esophageal Neoplasms, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to test 2 different methods of surgery to remove cancer in the esophagus. This research is being done to see whether removing more tissue and lymph nodes surrounding the tumor in the esophagus (known as transthoracic en bloc esophagectomy) offers better control of the cancer than removing… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Esophageal Neoplasms
- What is being tested?
- Esophagectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Apr 2012
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with cT2-T3/N0-N1-M1a-M1b(lymph node metastasis only) esophageal squamous cell and adenocarcinoma who have potentially resectable disease.
- 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.
- Age 18 or older.
- Patients may receive preoperative chemotherapy and/or radiation therapy as part of their clinical care.
Who cannot join
- Patients with clearly unresectable or metastatic esophageal cancer or clinical stage I esophageal cancer.
- Significant psychiatric illness that would interfere with patient compliance.
- Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment.
- Patients with a significant history of unstable cardiovascular disease (e.g., inadequately controlled hypertension, or angina; myocardial infarction within the previous 6 months; ventricular cardiac arrhythmias requiring medication; congestive heart failure 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Medical College of Cornell Unversity
New York, New York, 10065
About this study
Official title: A Phase III Study of En Bloc Versus Non-En Bloc Esophagectomy in Patients With Locally Advanced Esophageal Cancer
The purpose of this study is to test 2 different methods of surgery to remove cancer in the esophagus. This research is being done to see whether removing more tissue and lymph nodes surrounding the tumor in the esophagus (known as transthoracic en bloc esophagectomy) offers better control of the cancer than removing less tissue and lymph nodes (known as non-en bloc esophagectomy).
Read the detailed description
The aim of this study is to determine the 5-year disease-free survival, overall survival, and time to progression comparing (Arm A) transthoracic en bloc esophagectomy and (Arm B) transhiatal or transthoracic non-en bloc esophagectomy. Randomization to the two surgical arms will take place after the patient has given written informed consent and eligibility has been established. Patients will be informed of their randomized arm prior to the day of surgery. Preoperative chemotherapy may be administered at the discretion of the treating physician. Adjuvant chemotherapy and/or radiotherapy will be prescribed at the discretion of the treating physician. All patients will be followed for recurrence and survival for 5 years.
- Conditions
- Esophageal Neoplasms
- Being tested
- Esophagectomy
- Keywords
- Esophageal neoplasms, Esophagectomy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsophagectomyProcedure or surgery
Comparison of en-bloc vs. non-en bloc esophagectomy
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | En bloc esophagectomy is performed through a transthoracic approach by removing the tumor-bearing esophagus, the pericardium anteriorly, both pleural surfaces laterally, as well as the thoracic duct and all other lymphoareolar tissue wedged posteriorly between the esophagus and the spine, and en-bloc resection of all nodal groups in the middle and lower mediastinum as well as the upper abdomen. Receives: Procedure: Esophagectomy |
| B | Active comparator | Transhiatal esophagectomy is performed through an abdominal incision and a neck incision. The stomach is mobilized, and the left gastric vessels are transected at its origin. Celiac lymph nodes are dissected, and the intrathoracic esophagus is dissected bluntly through the hiatus and through the neck. The cervical esophagus is divided at the level of the neck. After the esophagogastrectomy is performed, a gastric tube is created. An esophagogastrostomy is then performed in the neck. If a transthoracic approach is used, dissection will be as described for the transhiatal approach. Receives: Procedure: Esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival defined as the time from surgical resection to the time of recurrent disease, death from esophageal cancer, or death from any cause.
Measured: CT scans will be performed every 6 months for 5 years.
Secondary outcomes (4)
To determine 5-year overall and disease-specific survival in arm A and arm B
Measured: CT scans every 6 months for 5 years
To determine the rates of local and systemic recurrence in arm A vs. arm B
Measured: CT scans performed every 6 months for 5 years
To determine time to progression in arm A vs. arm B
Measured: CT scans every 6 months for 5 years
To determine mortality and morbidity in arm A vs. arm B
Measured: 5 years from the date of surgical resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: Closed due to slow patient accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul C. Lee, Weill Medical College of Cornell University
- Investigators
- Paul C Lee, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760604
- Sponsor's protocol ID
- 0806009855
- Status last verified
- Aug 2012
- First submitted
- 25 Sep 2008
- Last updated
- 13 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of En Bloc Versus Non-En Bloc Esophagectomy in Patients With Locally Advanced Esophageal Cancer
- ClinicalTrials.gov ID
- NCT00760604
- Acronym / sponsor ID
- 0806009855
- Conditions
- Esophageal Neoplasms
- Keywords
- Esophageal neoplasms, Esophagectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed due to slow patient accrual.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 26 Sep 2008 (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 test 2 different methods of surgery to remove cancer in the esophagus. This research is being done to see whether removing more tissue and lymph nodes surrounding the tumor in the esophagus (known as transthoracic en bloc esophagectomy) offers better control of the cancer than removing less tissue and lymph nodes (known as non-en bloc esophagectomy).
Detailed description
The aim of this study is to determine the 5-year disease-free survival, overall survival, and time to progression comparing (Arm A) transthoracic en bloc esophagectomy and (Arm B) transhiatal or transthoracic non-en bloc esophagectomy. Randomization to the two surgical arms will take place after the patient has given written informed consent and eligibility has been established. Patients will be informed of their randomized arm prior to the day of surgery. Preoperative chemotherapy may be administered at the discretion of the treating physician. Adjuvant chemotherapy and/or radiotherapy will be prescribed at the discretion of the treating physician. All patients will be followed for recurrence and survival for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: EsophagectomyEn bloc esophagectomy is performed through a transthoracic approach by removing the tumor-bearing esophagus, the pericardium anteriorly, both pleural surfaces laterally, as well as the thoracic duct and all other lymphoareolar tissue wedged posteriorly between the esophagus and the spine, and en-bloc resection of all nodal groups in the middle and lower mediastinum as well as the upper abdomen. |
| B | Active comparator | Procedure: EsophagectomyTranshiatal esophagectomy is performed through an abdominal incision and a neck incision. The stomach is mobilized, and the left gastric vessels are transected at its origin. Celiac lymph nodes are dissected, and the intrathoracic esophagus is dissected bluntly through the hiatus and through the neck. The cervical esophagus is divided at the level of the neck. After the esophagogastrectomy is performed, a gastric tube is created. An esophagogastrostomy is then performed in the neck. If a transthoracic approach is used, dissection will be as described for the transhiatal approach. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with cT2-T3/N0-N1-M1a-M1b(lymph node metastasis only) esophageal squamous cell and adenocarcinoma who have potentially resectable disease.
- 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.
- Age 18 or older.
Key exclusion criteria (5 listed)
- Patients with clearly unresectable or metastatic esophageal cancer or clinical stage I esophageal cancer.
- Significant psychiatric illness that would interfere with patient compliance.
- Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment.
- Patients with a significant history of unstable cardiovascular disease (e.g., inadequately controlled hypertension, or angina; myocardial infarction within the previous 6 months; ventricular cardiac arrhythmias requiring medication; congestive heart failure 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.
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 |
|---|---|---|
| EsophagectomyComparison of en-bloc vs. non-en bloc esophagectomy | Procedure or surgery | A, B |
Primary outcome
Disease free survival defined as the time from surgical resection to the time of recurrent disease, death from esophageal cancer, or death from any cause.
Time frame: CT scans will be performed every 6 months for 5 years.
4 secondary outcomes
To determine 5-year overall and disease-specific survival in arm A and arm B
Time frame: CT scans every 6 months for 5 years
To determine the rates of local and systemic recurrence in arm A vs. arm B
Time frame: CT scans performed every 6 months for 5 years
To determine time to progression in arm A vs. arm B
Time frame: CT scans every 6 months for 5 years
To determine mortality and morbidity in arm A vs. arm B
Time frame: 5 years from the date of surgical resection
Results and safety
The study was stopped early (reason given: Closed due to slow patient accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2012.
Related trials for Esophageal Neoplasms
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
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.
Paul C Lee, M.D. principal investigator
Weill Medical College of Cornell University
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 Esophagectomy in people with Esophageal Neoplasms, run by Weill Medical College of Cornell University at 1 site in United States.
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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 13 Aug 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 United States. 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?
The study was stopped early (reason given: Closed due to slow patient accrual.). Results are not available in the source record.
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?
Disease free survival defined as the time from surgical resection to the time of recurrent disease, death from esophageal cancer, or death from any cause. (time frame: CT scans will be performed every 6 months for 5 years.). 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 13 Aug 2012.