NCT01927016

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,944

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2013

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

9 months

First QC Date

August 19, 2013

Last Update Submit

March 31, 2015

Conditions

Esophageal NeoplasmEsophageal Disease

Keywords

Esophageal NeoplasmEsophagusSurgeryOutcome assessment

Outcome Measures

Primary Outcomes (1)

  • To identify predictors of recurrence after esophageal cancer surgery

    clinical factors linked to 5-year recurrence will be identify through univariable and multivariable analysis

    30 May 2012

Secondary Outcomes (6)

  • 5 year recurrence free survival

    30 May 2012

  • 5 year overall survival

    30 may 2012

  • Predictors of postoperative mortality and morbidity after surgery

    30 May 2012

  • Impact of pCR on recurrence and survival

    30 May 2012

  • Impact of neoadjuvant treatments on recurrence and survival

    30 May 2012

  • +1 more secondary outcomes

Study Arms (1)

Esophagectomy for cancer

Patients operated on for a cancer of the esophagus, a Siewert I or II cancer of the oesophago-gastric junction

Procedure: Esophagectomy

Interventions

EsophagectomyPROCEDURE

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

Esophagectomy for cancer

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients operated on for a cancer of the esophagus , a Siewert I or II cancer of the oesophago-gastric junction

You may qualify if:

  • 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

You may not qualify if:

  • Siewert III cancer of the oesophago-gastric junction
  • Non surgical treatment of the esophageal cancer
  • Benign lesion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Lille

Lille, 59045, France

Location

Related Publications (4)

  • Teixeira-Farinha H, Behal H, Cailliau E, Pasquer A, Duhamel A, Thereaux J, Chalret du Rieu M, Lefevre JH, Turner K, Mantziari S, Collet D, Piessen G, Gronnier C; FREGAT Network-AFC Working Group. Impact of primary endoscopic resection on oncological outcomes after esophagectomy for cancer: a retrospective propensity score-based cohort study. Surg Endosc. 2024 Sep;38(9):5169-5177. doi: 10.1007/s00464-024-11077-2. Epub 2024 Jul 22.

    PMID: 39039292DERIVED

  • Markar SR, Gronnier C, Duhamel A, Pasquer A, Thereaux J, Chalret du Rieu M, Lefevre JH, Turner K, Luc G, Mariette C; FREGAT Working Group-FRENCH-AFC. Significance of Microscopically Incomplete Resection Margin After Esophagectomy for Esophageal Cancer. Ann Surg. 2016 Apr;263(4):712-8. doi: 10.1097/SLA.0000000000001325.

    PMID: 26135681DERIVED

  • Mariette C, Gronnier C, Duhamel A, Mabrut JY, Bail JP, Carrere N, Lefevre JH, Meunier B, Collet D, Piessen G; FREGAT Working Group-FRENCH-AFC; FREGAT Working Group-FRENCH-AFC. Self-expanding covered metallic stent as a bridge to surgery in esophageal cancer: impact on oncologic outcomes. J Am Coll Surg. 2015 Mar;220(3):287-96. doi: 10.1016/j.jamcollsurg.2014.11.028. Epub 2014 Dec 12.

    PMID: 25617915DERIVED

  • Gronnier C, Trechot B, Duhamel A, Mabrut JY, Bail JP, Carrere N, Lefevre JH, Brigand C, Vaillant JC, Adham M, Msika S, Demartines N, El Nakadi I, Piessen G, Meunier B, Collet D, Mariette C; FREGAT Working Group-FRENCH-AFC; Luc G, Cabau M, Jougon J, Badic B, Lozach P, Cappeliez S, Lebreton G, Alves A, Flamein R, Pezet D, Pipitone F, Iuga BS, Contival N, Pappalardo E, Mantziari S, Hec F, Vanderbeken M, Tessier W, Briez N, Fredon F, Gainant A, Mathonnet M, Bigourdan JM, Mezoughi S, Ducerf C, Baulieux J, Pasquer A, Baraket O, Poncet G, Vaudoyer D, Enfer J, Villeneuve L, Glehen O, Coste T, Fabre JM, Marchal F, Frisoni R, Ayav A, Brunaud L, Bresler L, Cohen C, Aze O, Venissac N, Pop D, Mouroux J, Donici I, Prudhomme M, Felli E, Lisunfui S, Seman M, Petit GG, Karoui M, Tresallet C, Menegaux F, Hannoun L, Malgras B, Lantuas D, Pautrat K, Pocard M, Valleur P. Impact of neoadjuvant chemoradiotherapy on postoperative outcomes after esophageal cancer resection: results of a European multicenter study. Ann Surg. 2014 Nov;260(5):764-70; discussion 770-1. doi: 10.1097/SLA.0000000000000955.

    PMID: 25379847DERIVED

MeSH Terms

Conditions

Esophageal NeoplasmsEsophageal Diseases

Interventions

Esophagectomy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Christophe Mariette, MD, PhD

    University Hospital, Lille

    STUDY DIRECTOR

  • Caroline Gronnier, MD

    CHRU LILLE

    PRINCIPAL INVESTIGATOR

  • Denis Collet, MD, PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Bernard Meunier, MD, PhD

    CHU Rennes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2013

First Posted

August 21, 2013

Study Start

July 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 1, 2015

Record last verified: 2015-03

Locations

FR(1)