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OpenTrials
Completed

NCT Number: NCT01927016

Outcomes After Esophageal Cancer Surgery

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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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, Lille

Lille, 59045, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esophagectomy

Procedure

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

Primary outcomes

  1. 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

  1. 5 year recurrence free survival

    Time frame: 30 May 2012

    events: death and recurrence at 5 years after surgery

  2. 5 year overall survival

    Time frame: 30 may 2012

    all causes for death at 5 years after surgery

  3. Predictors of postoperative mortality and morbidity after surgery

    Time frame: 30 May 2012

    30-day postoperative mortality and 30-day overall postoperative morbidity

  4. Impact of pCR on recurrence and survival

    Time frame: 30 May 2012

    pathological complete response within the tumor and nodes

  5. Impact of neoadjuvant treatments on recurrence and survival

    Time frame: 30 May 2012

    looking at the impact of neoadjuvant chemo and/or chemoradiation on oncological outcomes

  6. Impact of patient preconditioning (such as nutritional support, esophageal prosthesis, mini-invasive approach…) on outcomes

    Time frame: 30 May 2012

    looking at the impact of nutritional support, endoscopic and surgical procedures on outcomes

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • AFC (Association Francophone de Chirurgie)
  • Federation of Research in Surgery (FRENCH)
  • French Eso-Gastric Tumors Working Group

Registry information

Official study title

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

Acronym: FREGAT I

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 21, 2013
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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