Outcomes After Esophageal Cancer Surgery (FREGAT I)

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

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.

Study Overview

• Status: Completed
• Conditions: Esophageal Neoplasm; Esophageal Disease
• Intervention / Treatment: Procedure: Esophagectomy

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

• Study Type: Observational
• Enrollment (Actual): 2944

Contacts and Locations

Study Locations

• France
  • Lille, France, 59045
    • University Hospital, Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Esophagectomy for cancer; Patients operated on for a cancer of the esophagus, a Siewert I or II cancer of the oesophago-gastric junction	Procedure: Esophagectomy; Esophagectomy for esophageal cancer whatever can be the surgical approach (with or without thoracotomy, minimally invasive or not)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To identify predictors of recurrence after esophageal cancer surgery	clinical factors linked to 5-year recurrence will be identify through univariable and multivariable analysis	30 May 2012

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5 year recurrence free survival	events: death and recurrence at 5 years after surgery	30 May 2012
5 year overall survival	all causes for death at 5 years after surgery	30 may 2012
Predictors of postoperative mortality and morbidity after surgery	30-day postoperative mortality and 30-day overall postoperative morbidity	30 May 2012
Impact of pCR on recurrence and survival	pathological complete response within the tumor and nodes	30 May 2012
Impact of neoadjuvant treatments on recurrence and survival	looking at the impact of neoadjuvant chemo and/or chemoradiation on oncological outcomes	30 May 2012
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	30 May 2012

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Federation of Research in Surgery (FRENCH); French Eso-Gastric Tumors Working Group; AFC (Association Francophone de Chirurgie)
• Investigators: Study Director: Christophe Mariette, MD, PhD, University Hospital, Lille; Principal Investigator: Caroline Gronnier, MD, CHRU Lille; Principal Investigator: Denis Collet, MD, PhD, CHU Bordeaux; Principal Investigator: Bernard Meunier, MD, PhD, CHU Rennes

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: August 19, 2013
• First Submitted That Met QC Criteria: August 19, 2013
• First Posted (Estimate): August 21, 2013

Study Record Updates

• Last Update Posted (Estimate): April 1, 2015
• Last Update Submitted That Met QC Criteria: March 31, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Surgery; Esophagus; Esophageal Neoplasm; Outcome assessment
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Neoplasms; Esophageal Diseases
• Other Study ID Numbers: 2013_01