University Hospital, Lille
Lille, 59045, France
NCT Number: NCT01927016
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.
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Notify Me18 year–90 year
All sexes
Observational
Lille, 59045, France
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Esophagectomy for esophageal cancer whatever can be the surgical approach (with or without thoracotomy, minimally invasive or not)
Time frame: 30 May 2012
clinical factors linked to 5-year recurrence will be identify through univariable and multivariable analysis
Time frame: 30 May 2012
events: death and recurrence at 5 years after surgery
Time frame: 30 may 2012
all causes for death at 5 years after surgery
Time frame: 30 May 2012
30-day postoperative mortality and 30-day overall postoperative morbidity
Time frame: 30 May 2012
pathological complete response within the tumor and nodes
Time frame: 30 May 2012
looking at the impact of neoadjuvant chemo and/or chemoradiation on oncological outcomes
Time frame: 30 May 2012
looking at the impact of nutritional support, endoscopic and surgical procedures on outcomes
University Hospital, Lille
Other
Factors Linked to Outcomes After Esophageal Cancer Surgery: a Multicenter National Study
Acronym: FREGAT I
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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