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Outcomes After Esophageal Cancer Surgery (FREGAT I)

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ClinicalTrials.gov Identifier: NCT01927016
Recruitment Status : Completed
First Posted : August 21, 2013
Last Update Posted : April 1, 2015
Sponsor:
Collaborators:
French Eso-Gastric Tumors Working Group
Federation of Research in Surgery (FRENCH)
AFC (Association Francophone de Chirurgie)
Information provided by (Responsible Party):
University Hospital, Lille

Tracking Information
First Submitted Date August 19, 2013
First Posted Date August 21, 2013
Last Update Posted Date April 1, 2015
Study Start Date July 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 16, 2014)
To identify predictors of recurrence after esophageal cancer surgery [ Time Frame: 30 May 2012 ]
clinical factors linked to 5-year recurrence will be identify through univariable and multivariable analysis
Original Primary Outcome Measures
 (submitted: August 19, 2013)
To identify predictors of recurrence after esophageal cancer surgery [ Time Frame: 30 May 2012 ]
Change History
Current Secondary Outcome Measures
 (submitted: September 16, 2014)
  • 5 year recurrence free survival [ Time Frame: 30 May 2012 ]
    events: death and recurrence at 5 years after surgery
  • 5 year overall survival [ Time Frame: 30 may 2012 ]
    all causes for death at 5 years after surgery
  • Predictors of postoperative mortality and morbidity after surgery [ Time Frame: 30 May 2012 ]
    30-day postoperative mortality and 30-day overall postoperative morbidity
  • Impact of pCR on recurrence and survival [ Time Frame: 30 May 2012 ]
    pathological complete response within the tumor and nodes
  • Impact of neoadjuvant treatments on recurrence and survival [ Time Frame: 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 [ Time Frame: 30 May 2012 ]
    looking at the impact of nutritional support, endoscopic and surgical procedures on outcomes
Original Secondary Outcome Measures
 (submitted: August 19, 2013)
  • 5 year recurrence free survival [ Time Frame: 30 May 2012 ]
  • 5 year overall survival [ Time Frame: 30 may 2012 ]
  • Predictors of postoperative mortality and mobidity after surgery [ Time Frame: 30 May 2012 ]
  • Impact of pCR on recurrence and survival [ Time Frame: 30 May 2012 ]
  • Impact of neoadjuvant treatments on recurrence and survival [ Time Frame: 30 May 2012 ]
  • Impact of patient preconditioning (such as nutritional support, esophageal prosthesis, mini-invasive approach…) on outcomes [ Time Frame: 30 May 2012 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Outcomes After Esophageal Cancer Surgery
Official Title Factors Linked to Outcomes After Esophageal Cancer Surgery: a Multicenter National Study
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Esophageal Neoplasm
  • Esophageal Disease
Intervention Procedure: Esophagectomy
Esophagectomy for esophageal cancer whatever can be the surgical approach (with or without thoracotomy, minimally invasive or not)
Study Groups/Cohorts Esophagectomy for cancer
Patients operated on for a cancer of the esophagus, a Siewert I or II cancer of the oesophago-gastric junction
Intervention: Procedure: Esophagectomy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 19, 2013)
2944
Original Actual Enrollment Same as current
Actual Study Completion Date April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01927016
Other Study ID Numbers 2013_01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Lille
Study Sponsor University Hospital, Lille
Collaborators
  • French Eso-Gastric Tumors Working Group
  • Federation of Research in Surgery (FRENCH)
  • 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
PRS Account University Hospital, Lille
Verification Date March 2015