Clinical Trials Directory

Trials / Completed

CompletedNCT01927016

Outcomes After Esophageal Cancer Surgery

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

Status
Completed
Phase
Study type
Observational
Enrollment
2,944 (actual)
Sponsor
University Hospital, Lille · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
PROCEDUREEsophagectomyEsophagectomy for esophageal cancer whatever can be the surgical approach (with or without thoracotomy, minimally invasive or not)

Timeline

Start date
2012-07-01
Primary completion
2013-04-01
Completion
2013-04-01
First posted
2013-08-21
Last updated
2015-04-01

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01927016. Inclusion in this directory is not an endorsement.