Factors Linked to Outcomes After Esophageal Cancer Surgery: a Multicenter National Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2,944
- Locations
- 2
- Primary Endpoint
- To identify predictors of recurrence after esophageal cancer surgery
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Predictors of postoperative mortality and morbidity after surgery(30 May 2012)
- 5 year recurrence free survival(30 May 2012)
- Impact of pCR on recurrence and survival(30 May 2012)
- Impact of neoadjuvant treatments on recurrence and survival(30 May 2012)
- Impact of patient preconditioning (such as nutritional support, esophageal prosthesis, mini-invasive approach…) on outcomes(30 May 2012)
- 5 year overall survival(30 may 2012)