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Esophageal NeoplasmFREGAT INCT01927016

Outcomes After Esophageal Cancer Surgery

An observational study of Esophageal Neoplasm and Esophageal Disease, run by University Hospital, Lille at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background Esophageal carcinoma is the sixth leading cause of cancer -related mortality and the eighth most common cancer worldwide The incidence is increasing rapidly The overall 5-year survival ranges from 15% to 25% in the literature and poor outcomes are related to diagnosis at advanced stages. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Esophageal Neoplasm, Esophageal Disease
What is being tested?
Esophagectomy
Type of treatment
Surgery or procedure
How many people
2,944 participants
Where
1 siteFrance
Study dates
Jul 2012to Apr 2013
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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients operated on for a cancer of the esophagus , a Siewert I or II cancer of the oesophago-gastric junction

Who may be able to join

  • All consecutive patients operated on for a cancer of the esophagus , a Siewert I or II cancer of the esopgago-gastric junction in surgical oncology investigator centers
  • Surgery performed between 1st January 2000 and 31 December 2010

Who cannot join

  • Siewert III cancer of the oesophago-gastric junction
  • Non surgical treatment of the esophageal cancer
  • Benign lesion

Trial locations and contacts

1 site in 1 country.

France1 site

  • University Hospital, Lille

    Lille, 59045

Other trials in France

About this study

Official title: Factors Linked to Outcomes After Esophageal Cancer Surgery: a Multicenter National Study

Background

  • Esophageal carcinoma is the sixth leading cause of cancer -related mortality and the eighth most common cancer worldwide
  • The incidence is increasing rapidly
  • The overall 5-year survival ranges from 15% to 25% in the literature and poor outcomes are related to diagnosis at advanced stages.
  • Surgery used to be the cornerstone of treatment of resectable esophageal cancer, but treatment of esophageal carcinoma remains challenging and need to be considered through a multimodal approach. However the modalities and the impact of this multimodal approach at a national level are unknown Primary objective: To identify predictors of recurrence after esophageal cancer surgery
Read more

Secondary objectives :

  • 5-year recurrence free survival
  • 5-year overall survival
  • Predictors of postoperative mortality and morbidity after surgery
  • Impact of pCR on recurrence and survival
  • Impact of neoadjuvant treatments on recurrence and survival
  • Impact of patient preconditioning (such as nutritional support, esophageal prosthesis, mini-invasive approach…) on outcomes

Methodology : European French-speaking retrospective multicentric study Inclusion criteria: All consecutive patients operated on, for a histologically proven carcinoma of the esophagus, the oesophago-gastric junction (Siewert type I and II), in surgical investigator centers between January 2000 and December 2010 Exclusion criteria: Siewert III type carcinoma of the oesophago-gastric junction , non surgical treatment of esophageal carcinoma Planned study period: The data will be collected over a 11-year period from January 2000 to December 2010. Follow up will be ascertained in May 2013.

Read the detailed description

Patients with an esophageal or junctional carcinoma (including SIewert type I and II) with surgical resection of the primary tumor inclusion date will be date of surgery all patients will be followed during 5 years after surgery or time of death

Being tested
Esophagectomy
Keywords
Esophageal Neoplasm, Esophagus, Surgery, Outcome assessment
Medical subject headings
Esophageal Neoplasms, Esophageal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EsophagectomyProcedure or surgery

    Esophagectomy for esophageal cancer whatever can be the surgical approach (with or without thoracotomy, minimally invasive or not)

Study groups in NCT01927016
Study groupRoleWhat they receive
Esophagectomy for cancerPatients operated on for a cancer of the esophagus, a Siewert I or II cancer of the oesophago-gastric junction
Receives: Procedure: Esophagectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To identify predictors of recurrence after esophageal cancer surgery

    clinical factors linked to 5-year recurrence will be identify through univariable and multivariable analysis

    Measured: 30 May 2012

Secondary outcomes (6)

  1. 5 year recurrence free survival

    events: death and recurrence at 5 years after surgery

    Measured: 30 May 2012

  2. 5 year overall survival

    all causes for death at 5 years after surgery

    Measured: 30 may 2012

  3. Predictors of postoperative mortality and morbidity after surgery

    30-day postoperative mortality and 30-day overall postoperative morbidity

    Measured: 30 May 2012

  4. Impact of pCR on recurrence and survival

    pathological complete response within the tumor and nodes

    Measured: 30 May 2012

  5. Impact of neoadjuvant treatments on recurrence and survival

    looking at the impact of neoadjuvant chemo and/or chemoradiation on oncological outcomes

    Measured: 30 May 2012

  6. Impact of patient preconditioning (such as nutritional support, esophageal prosthesis, mini-invasive approach…) on outcomes

    looking at the impact of nutritional support, endoscopic and surgical procedures on outcomes

    Measured: 30 May 2012

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2013 (estimated)
  2. Study startJul 2012
  3. Primary completionApr 2013
  4. Study completionApr 2013

Resources

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
2,944 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01927016
Sponsor's protocol ID
2013_01
Acronym
FREGAT I
Status last verified
Mar 2015
First submitted
19 Aug 2013
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Mariette C, Gronnier C, Duhamel A, Mabrut JY, Bail JP, Carrere N, Lefevre JH, Meunier B, Collet D, Piessen G; FREGAT Working Group-FRENCH-AFC; FREGAT Working Group-FRENCH-AFC. Self-expanding covered metallic stent as a bridge to surgery in esophageal cancer: impact on oncologic outcomes. J Am Coll Surg. 2015 Mar;220(3):287-96. doi: 10.1016/j.jamcollsurg.2014.11.028. Epub 2014 Dec 12.

    PubMed 25617915

  • Teixeira-Farinha H, Behal H, Cailliau E, Pasquer A, Duhamel A, Thereaux J, Chalret du Rieu M, Lefevre JH, Turner K, Mantziari S, Collet D, Piessen G, Gronnier C; FREGAT Network-AFC Working Group. Impact of primary endoscopic resection on oncological outcomes after esophagectomy for cancer: a retrospective propensity score-based cohort study. Surg Endosc. 2024 Sep;38(9):5169-5177. doi: 10.1007/s00464-024-11077-2. Epub 2024 Jul 22.

    PubMed 39039292

  • Markar SR, Gronnier C, Duhamel A, Pasquer A, Thereaux J, Chalret du Rieu M, Lefevre JH, Turner K, Luc G, Mariette C; FREGAT Working Group-FRENCH-AFC. Significance of Microscopically Incomplete Resection Margin After Esophagectomy for Esophageal Cancer. Ann Surg. 2016 Apr;263(4):712-8. doi: 10.1097/SLA.0000000000001325.

    PubMed 26135681

  • Gronnier C, Trechot B, Duhamel A, Mabrut JY, Bail JP, Carrere N, Lefevre JH, Brigand C, Vaillant JC, Adham M, Msika S, Demartines N, El Nakadi I, Piessen G, Meunier B, Collet D, Mariette C; FREGAT Working Group-FRENCH-AFC; Luc G, Cabau M, Jougon J, Badic B, Lozach P, Cappeliez S, Lebreton G, Alves A, Flamein R, Pezet D, Pipitone F, Iuga BS, Contival N, Pappalardo E, Mantziari S, Hec F, Vanderbeken M, Tessier W, Briez N, Fredon F, Gainant A, Mathonnet M, Bigourdan JM, Mezoughi S, Ducerf C, Baulieux J, Pasquer A, Baraket O, Poncet G, Vaudoyer D, Enfer J, Villeneuve L, Glehen O, Coste T, Fabre JM, Marchal F, Frisoni R, Ayav A, Brunaud L, Bresler L, Cohen C, Aze O, Venissac N, Pop D, Mouroux J, Donici I, Prudhomme M, Felli E, Lisunfui S, Seman M, Petit GG, Karoui M, Tresallet C, Menegaux F, Hannoun L, Malgras B, Lantuas D, Pautrat K, Pocard M, Valleur P. Impact of neoadjuvant chemoradiotherapy on postoperative outcomes after esophageal cancer resection: results of a European multicenter study. Ann Surg. 2014 Nov;260(5):764-70; discussion 770-1. doi: 10.1097/SLA.0000000000000955.

    PubMed 25379847

Questions about this trial

What is this clinical trial studying?

An observational study of Esophageal Neoplasm and Esophageal Disease, run by University Hospital, Lille at 1 site in France.

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 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: finished, as of the sponsor's last update on 14 May 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 France. 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?

To identify predictors of recurrence after esophageal cancer surgery (time frame: 30 May 2012). 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 NCT01927016, which also lists 4 linked publications.

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 14 May 2026.

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