FREGAT I: Outcomes After Esophageal Cancer Surgery

Sponsor

University Hospital, Lille (Other)

Overall Status

Completed

CT.gov ID

NCT01927016

Collaborator

French Eso-Gastric Tumors Working Group (Other), Federation of Research in Surgery (FRENCH) (Other), AFC (Association Francophone de Chirurgie) (Other)

2,944

Enrollment

Location

Duration (Months)

327

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Neoplasm Esophageal Disease	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 Design

Study Type:

Observational

Actual Enrollment :

2944 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	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)

Arm

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)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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