Outcomes After Esophageal Cancer Surgery

NCT ID: NCT01927016

Last Updated: 2015-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2944 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Neoplasm Esophageal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Esophagectomy for cancer

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

Esophagectomy

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Esophagectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Siewert III cancer of the oesophago-gastric junction
* Non surgical treatment of the esophageal cancer
* Benign lesion
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

French Eso-Gastric Tumors Working Group

OTHER

Sponsor Role collaborator

Federation of Research in Surgery (FRENCH)

OTHER

Sponsor Role collaborator

AFC (Association Francophone de Chirurgie)

UNKNOWN

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christophe Mariette, MD, PhD

Role: STUDY_DIRECTOR

University Hospital, Lille

Caroline Gronnier, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU LILLE

Denis Collet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Bernard Meunier, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital, Lille

Lille, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39039292 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26135681 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25617915 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25379847 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013_01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.