Outcomes After Esophageal Cancer Surgery

Esophageal Neoplasm Clinical Trial

— FREGAT I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01927016
• Other study ID #: 2013_01
• Status: Completed
• Phase: N/A
• First received: August 19, 2013
• Last updated: March 31, 2015
• Start date: July 2012
• Est. completion date: April 2013

Study information

• Verified date: March 2015
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life Sciences
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2944
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Esophageal Disease
• Esophageal Diseases
• Esophageal Neoplasm
• Esophageal Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	University Hospital, Lille	Lille

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Lille	AFC (Association Francophone de Chirurgie), FRENCH (Fédération de Recherche en chirurgie ), French Eso-Gastric Tumors Working Group

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	5 year recurrence free survival	events: death and recurrence at 5 years after surgery	30 May 2012	No
Secondary	5 year overall survival	all causes for death at 5 years after surgery	30 may 2012	No
Secondary	Predictors of postoperative mortality and morbidity after surgery	30-day postoperative mortality and 30-day overall postoperative morbidity	30 May 2012	Yes
Secondary	Impact of pCR on recurrence and survival	pathological complete response within the tumor and nodes	30 May 2012	No
Secondary	Impact of neoadjuvant treatments on recurrence and survival	looking at the impact of neoadjuvant chemo and/or chemoradiation on oncological outcomes	30 May 2012	No
Secondary	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	No