Esophageal CancerNCT05706558
Retrospective Review of Esophageal Cancer at MSKCC
An observational study of Esophageal Cancer and Esophagus Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Residual tumor at the proximal or distal margin after esophagectomy is a known prognostic factor for poor survival outcomes in patients with esophageal cancer; however, the significance of the circumferential resection margin (CRM) remains controversial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Esophagus Cancer
- What is being tested?
- Esophagectomy
- Type of treatment
- Surgery or procedure
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2016to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants undergoing esophagectomy for histologically confirmed esophageal adenocarcinoma (EAC) or esophageal squamous cell carcinoma (ESCC) during the period from 2000 to 2019.
Who may be able to join
- Histologically confirmed esophageal adenocarcinoma (EAC) or esophageal squamous cell carcinoma (ESCC) undergoing esophagectomy
- Pathologic staged T3 tumors (pT3)
Who cannot join
- Pathologic staged T0-2 (pT0-2) or T4 tumors (pT4)
- Patients with histologic types other than EAC or ESCC, dysplasia or carcinoma in situ without tumor invasion,
- Patients undergoing salvage esophagectomy
- Evidence of distant metastatic disease
- Patients with a positive proximal or distal margin
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Daniela Molena, MD, 212-639-3870
About this study
Residual tumor at the proximal or distal margin after esophagectomy is a known prognostic factor for poor survival outcomes in patients with esophageal cancer; however, the significance of the circumferential resection margin (CRM) remains controversial. In this study, the investigators sought to evaluate the prognostic significance of the CRM in patients with esophageal cancer undergoing resection.
- Conditions
- Esophageal Cancer, Esophagus Cancer
- Being tested
- Esophagectomy
- Keywords
- Esophageal Cancer, Esophagus Cancer, Memorial Sloan Kettering Cancer Center, 16-1631
- 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
Esophagectomy
| Study group | Role | What they receive |
|---|---|---|
| Circumferential resection margin (CRM) | Participants will have a diagnosis of esophageal carcinoma and residual tumor >1 mm from the CRM Receives: Procedure: Esophagectomy | |
| Circumferential resection margin (CRM)-close | Participants will have a diagnosis of esophageal carcinoma and residual tumor >0-1 mm from the CRM Receives: Procedure: Esophagectomy | |
| Circumferential resection margin (CRM)+ | Participants will have a diagnosis of esophageal carcinoma and residual tumor at the surgical CRM Receives: Procedure: Esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
. Preoperative variables associated with overall survival and progression-free survival (measured from date of surgery)
Preoperative variables associated with overall survival and progression-free survival (measured from date of surgery) and the association between patient characteristics, neoadjuvant therapy, and postoperative morbidity.
Measured: Up to 2 years
Secondary outcomes (4)
Overall survival and progression-free survival (measured from date of surgery)
Postoperative outcomes stratified by the type of esophageal cancer surgery performed.
Measured: Up to 2 years
Postoperative outcomes stratified by the time between neoadjuvant therapy and surgery (i.e., delayed or immediate).
Measured: Up to 2 years
Survival outcomes stratified by treatment modality (i.e., definitive chemoradiation therapy or trimodality treatment).
Measured: Up to 2 years
Survival outcomes stratified by use of adjuvant therapy (i.e., adjuvant therapy or no adjuvant therapy).
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start13 Dec 2016
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (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 Memorial Sloan Kettering Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniela Molena, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706558
- Sponsor's protocol ID
- 16-1631
- Status last verified
- Sep 2026
- First submitted
- 23 Jan 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Review of Esophageal Cancer at MSKCC
- ClinicalTrials.gov ID
- NCT05706558
- Acronym / sponsor ID
- 16-1631
- Conditions
- Esophageal Cancer, Esophagus Cancer
- Keywords
- Esophageal Cancer, Esophagus Cancer, Memorial Sloan Kettering Cancer Center, 16-1631
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 13 Dec 2016 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 31 Jan 2023 (actual)
- 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.
Residual tumor at the proximal or distal margin after esophagectomy is a known prognostic factor for poor survival outcomes in patients with esophageal cancer; however, the significance of the circumferential resection margin (CRM) remains controversial. In this study, the investigators sought to evaluate the prognostic significance of the CRM in patients with esophageal cancer undergoing resection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Circumferential resection margin (CRM) | – | Procedure: EsophagectomyParticipants will have a diagnosis of esophageal carcinoma and residual tumor >1 mm from the CRM |
| Circumferential resection margin (CRM)-close | – | Procedure: EsophagectomyParticipants will have a diagnosis of esophageal carcinoma and residual tumor >0-1 mm from the CRM |
| Circumferential resection margin (CRM)+ | – | Procedure: EsophagectomyParticipants will have a diagnosis of esophageal carcinoma and residual tumor at the surgical CRM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants undergoing esophagectomy for histologically confirmed esophageal adenocarcinoma (EAC) or esophageal squamous cell carcinoma (ESCC) during the period from 2000 to 2019.
Key inclusion criteria (2 listed)
- Histologically confirmed esophageal adenocarcinoma (EAC) or esophageal squamous cell carcinoma (ESCC) undergoing esophagectomy
- Pathologic staged T3 tumors (pT3)
Key exclusion criteria (5 listed)
- Pathologic staged T0-2 (pT0-2) or T4 tumors (pT4)
- Patients with histologic types other than EAC or ESCC, dysplasia or carcinoma in situ without tumor invasion,
- Patients undergoing salvage esophagectomy
- Evidence of distant metastatic disease
- Patients with a positive proximal or distal margin
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 |
|---|---|---|
| EsophagectomyEsophagectomy | Procedure or surgery | Circumferential resection margin (CRM), Circumferential resection margin (CRM)+, Circumferential resection margin (CRM)-close |
Primary outcome
. Preoperative variables associated with overall survival and progression-free survival (measured from date of surgery)
Time frame: Up to 2 years
Preoperative variables associated with overall survival and progression-free survival (measured from date of surgery) and the association between patient characteristics, neoadjuvant therapy, and postoperative morbidity.
4 secondary outcomes
Overall survival and progression-free survival (measured from date of surgery)
Time frame: Up to 2 years
Postoperative outcomes stratified by the time between neoadjuvant therapy and surgery (i.e., delayed or immediate).
Time frame: Up to 2 years
Survival outcomes stratified by treatment modality (i.e., definitive chemoradiation therapy or trimodality treatment).
Time frame: Up to 2 years
Survival outcomes stratified by use of adjuvant therapy (i.e., adjuvant therapy or no adjuvant therapy).
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Daniela Molena, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Esophagus Cancer, run by Memorial Sloan Kettering Cancer Center 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 2 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniela Molena, MD (212-639-3870, molenad@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
. Preoperative variables associated with overall survival and progression-free survival (measured from date of surgery) (time frame: Up to 2 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 9 Sep 2026.