Outcomes After Esophageal Cancer Surgery

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Esophageal Neoplasm, Esophageal Disease

Intervention / Treatment
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* Procedure: Esophagectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Neoplasm, Esophagus, Surgery, Outcome assessment