Clinical trial NCT01927016: Outcomes After Esophageal Cancer Surgery
Official title: Factors Linked to Outcomes After Esophageal Cancer Surgery: a Multicenter National Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Neoplasm
Esophageal Disease
Keywords: Esophageal Neoplasm
Esophagus
Surgery
Outcome assessment
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: French Eso-Gastric Tumors Working Group
name: Federation of Research in Surgery (FRENCH)
name: AFC (Association Francophone de Chirurgie)
First posted: 2013-08-21
Enrollment: 2944
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients operated on for a cancer of the esophagus , a Siewert I or II cancer of the oesophago-gastric junction

Brief 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.
* 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: To identify predictors of recurrence after esophageal cancer surgery
timeFrame: 30 May 2012
Secondary outcomes:
measure: 5 year recurrence free survival
timeFrame: 30 May 2012
measure: 5 year overall survival
timeFrame: 30 may 2012
measure: Predictors of postoperative mortality and morbidity after surgery
timeFrame: 30 May 2012
measure: Impact of pCR on recurrence and survival
timeFrame: 30 May 2012
measure: Impact of neoadjuvant treatments on recurrence and survival
timeFrame: 30 May 2012
measure: Impact of patient preconditioning (such as nutritional support, esophageal prosthesis, mini-invasive approach…) on outcomes
timeFrame: 30 May 2012
Other outcomes:
Locations:
city: Lille
country: France
facility: University Hospital, Lille
Study officials:
affiliation: University Hospital, Lille
name: Christophe Mariette, MD, PhD
role: STUDY_DIRECTOR
affiliation: CHRU LILLE
name: Caroline Gronnier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Denis Collet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rennes
name: Bernard Meunier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.