NCT01525953

Brief Summary

The aim of this study is to identify prognostic factors for outcome in patients being complete clinical responders with chemoradiation or radiation for esophageal cancer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

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

January 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 3, 2012

Completed
Last Updated

February 3, 2012

Status Verified

February 1, 2012

Enrollment Period

Same day

First QC Date

January 30, 2012

Last Update Submit

February 1, 2012

Conditions

Esophageal Cancer

Keywords

esophageal cancerradiochemotherapyprognosis

Outcome Measures

Primary Outcomes (1)

  • Identification of prognostic factors for overall survival

    Correlation between survival and baseline,clinical and treatment characteristics

    From date of treatment until death, assessed up to 10 years

Secondary Outcomes (2)

  • Patterns of treatment failure

    From date of treatment until treatment failure, assessed up to 10 years

  • Disease-free survival

    From date of treatment until progression or death, assessed up to 10 years

Interventions

ChemotherapyDRUG

Chemotherapy according to standard

RadiotherapyRADIATION

Radiotherapy according to local standard

Eligibility Criteria

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

Patient treated for esophageal cancer in the Northern France Cancer Center from january 1998 to december 2003

You may qualify if:

  • localized or locally advanced esophageal cancer
  • patient who underwent definite chemoradiation or radiation
  • patient with complete clinical response

You may not qualify if:

  • metastatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Oscar LAMBRET

Lille, 59000, France

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Drug TherapyRadiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Antoine ADENIS, MD, PhD

    Centre Oscar Lambret

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 30, 2012

First Posted

February 3, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

February 3, 2012

Record last verified: 2012-02

Locations

FR(1)