Outcomes After Esophageal Cancer Surgery

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01927016

Acronym

FREGAT I

Enrollment

2944

Registered

2013-08-21

Start date

2012-07-01

Completion date

2013-04-01

Last updated

2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Disease, Esophageal Neoplasm

Keywords

Esophageal Neoplasm, Esophagus, Surgery, Outcome assessment

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

Interventions

PROCEDUREEsophagectomy

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
5 year recurrence free survival	30 May 2012	events: death and recurrence at 5 years after surgery
5 year overall survival	30 may 2012	all causes for death at 5 years after surgery
Predictors of postoperative mortality and morbidity after surgery	30 May 2012	30-day postoperative mortality and 30-day overall postoperative morbidity
Impact of pCR on recurrence and survival	30 May 2012	pathological complete response within the tumor and nodes
Impact of neoadjuvant treatments on recurrence and survival	30 May 2012	looking at the impact of neoadjuvant chemo and/or chemoradiation on oncological outcomes
Impact of patient preconditioning (such as nutritional support, esophageal prosthesis, mini-invasive approach…) on outcomes	30 May 2012	looking at the impact of nutritional support, endoscopic and surgical procedures on outcomes

Countries

France

Contacts

STUDY_DIRECTORChristophe Mariette, MD, PhD

University Hospital, Lille

PRINCIPAL_INVESTIGATORCaroline Gronnier, MD

CHRU LILLE

PRINCIPAL_INVESTIGATORDenis Collet, MD, PhD

University Hospital, Bordeaux

PRINCIPAL_INVESTIGATORBernard Meunier, MD, PhD

Rennes University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026