Esophageal CancerNCT01959906
Circumferential Section Pane Less Than 1 mm in Esophagectomy for Esophageal Cancer.
An observational study of Esophageal Cancer, run by University Hospital, Gasthuisberg at 1 site in Belgium.
Trial summary
A suspicious circumferential resection margin (CRM), defined as tumor cells within 1 mm of the CRM, is still controversial. The aim of this study was to compare the clinical significance of a suspicious CRM to histologically positive (R1) and negative margin (R0) resections in patients with pT3 esophageal and… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Esophageal Cancer
- How many people
- 923 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2013to Jun 2014
- Phase
- Observational
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 923 consecutive pT3 patients operated between january 1990 and june 2013
Who may be able to join
- pathologic T3 tumours of esophagus or GEJ
Who cannot join
- pT other than pT3
- R2 resections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Value of a Circumferential Section Pane Less Than 1 mm in Esophagectomy for Esophageal Cancer.
A suspicious circumferential resection margin (CRM), defined as tumor cells within 1 mm of the CRM, is still controversial. The aim of this study was to compare the clinical significance of a suspicious CRM to histologically positive (R1) and negative margin (R0) resections in patients with pT3 esophageal and GE-Junction tumors.
Read the detailed description
From our prospectively build database 923 consecutive pT3 patients operated between january 1990 and june 2013 were selected. CRM status in patients treated by surgery only (n = 747) or after neoadjuvant therapy (n = 176) was recorded prospectively after surgery.
Kaplan-Meier survival curves were generated, and factors affecting survival were assessed by Cox regression multivariate analysis.
- Conditions
- Esophageal Cancer
- Keywords
- 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.
| Study group | Role | What they receive |
|---|---|---|
| R0 | Complete resection | |
| R1 | Incomplete resection, microscopical tumor residu left behind | |
| CRM<1mm | complete resection (R0), however tumor spreads till less than 1 mm from the section pane. |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
5 years overall survival after esophagectomy
Measured: 5 years after esophagectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2013 (estimated)
- Study completionJun 2014 (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.
- 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
- 923 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johnny Moons, University Hospital, Gasthuisberg
- Investigators
- Philippe Nafteux, MD, Study director, University Hospital Leuven, dept. Thoracic SurgeryKatrien Van de Steen, MSc, Principal investigator, Katholic University Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959906
- Sponsor's protocol ID
- CRM<1mm
- Status last verified
- Oct 2013
- First submitted
- 8 Oct 2013
- Last updated
- 10 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of a Circumferential Section Pane Less Than 1 mm in Esophagectomy for Esophageal Cancer.
- ClinicalTrials.gov ID
- NCT01959906
- Acronym / sponsor ID
- CRM<1mm
- Conditions
- Esophageal Cancer
- Keywords
- Esophagectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 923 participants (actual)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 10 Oct 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.
A suspicious circumferential resection margin (CRM), defined as tumor cells within 1 mm of the CRM, is still controversial. The aim of this study was to compare the clinical significance of a suspicious CRM to histologically positive (R1) and negative margin (R0) resections in patients with pT3 esophageal and GE-Junction tumors.
Detailed description
From our prospectively build database 923 consecutive pT3 patients operated between january 1990 and june 2013 were selected. CRM status in patients treated by surgery only (n = 747) or after neoadjuvant therapy (n = 176) was recorded prospectively after surgery.
Kaplan-Meier survival curves were generated, and factors affecting survival were assessed by Cox regression multivariate analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| R0 | – | –Complete resection |
| R1 | – | –Incomplete resection, microscopical tumor residu left behind |
| CRM<1mm | – | –complete resection (R0), however tumor spreads till less than 1 mm from the section pane. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 923 consecutive pT3 patients operated between january 1990 and june 2013
Key inclusion criteria (1 listed)
- pathologic T3 tumours of esophagus or GEJ
Key exclusion criteria (2 listed)
- pT other than pT3
- R2 resections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
overall survival
Time frame: 5 years after esophagectomy
5 years overall survival after esophagectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2013.
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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.
Philippe Nafteux, MD study director
University Hospital Leuven, dept. Thoracic Surgery
Katrien Van de Steen, MSc principal investigator
Katholic University Leuven
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, run by University Hospital, Gasthuisberg at 1 site in Belgium.
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 1 inclusion and 2 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 10 Oct 2013. 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 Belgium. 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?
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?
overall survival (time frame: 5 years after esophagectomy). 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 10 Oct 2013.