Outcomes After Esophageal Cancer Surgery
- Conditions
- Esophageal NeoplasmEsophageal Disease
- Interventions
- Procedure: Esophagectomy
- Registration Number
- NCT01927016
- Lead Sponsor
- University Hospital, Lille
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2944
- 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
- Siewert III cancer of the oesophago-gastric junction
- Non surgical treatment of the esophageal cancer
- Benign lesion
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Esophagectomy for cancer Esophagectomy Patients operated on for a cancer of the esophagus, a Siewert I or II cancer of the oesophago-gastric junction
- Primary Outcome Measures
Name Time Method 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
Name Time Method Predictors of postoperative mortality and morbidity after surgery 30 May 2012 30-day postoperative mortality and 30-day overall postoperative morbidity
5 year recurrence free survival 30 May 2012 events: death and recurrence at 5 years after surgery
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
5 year overall survival 30 may 2012 all causes for death at 5 years after surgery
Trial Locations
- Locations (1)
University Hospital, Lille
🇫🇷Lille, France