Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
Study NCT ID:
NCT01927016
Status:
COMPLETED
Last Update Posted:
2015-04-01
First Post:
2013-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcomes After Esophageal Cancer Surgery
Sponsor:
University Hospital, Lille
Organization:
Study Overview
Official Title:
Factors Linked to Outcomes After Esophageal Cancer Surgery: a Multicenter National Study
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FREGAT I
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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: