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Complete Clinical Responders to Definite Chemoradiation in Esophageal Cancer : a Survival Analysis (CRCRT-EC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01525953
First received: January 30, 2012
Last updated: February 1, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition Intervention
Esophageal Cancer
 Drug: Chemotherapy
Radiation: Radiotherapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Predictors of Survival for Complete Clinical Responders to Definite Chemoradiation or Radiation Therapy for Esophageal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • Identification of prognostic factors for overall survival [ Time Frame: From date of treatment until death, assessed up to 10 years ] [ Designated as safety issue: No ]
    Correlation between survival and baseline,clinical and treatment characteristics


Secondary Outcome Measures:
  • Patterns of treatment failure [ Time Frame: From date of treatment until treatment failure, assessed up to 10 years ] [ Designated as safety issue: No ]
    Type of recurrence : local, regional, distant.

  • Disease-free survival [ Time Frame: From date of treatment until progression or death, assessed up to 10 years ] [ Designated as safety issue: No ]
    Time between the end of treatment and the occurence of progression


Enrollment: 110
Study Start Date: January 2012
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Chemotherapy
    Chemotherapy according to standard
    Radiation: Radiotherapy
    Radiotherapy according to local standard
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • metastatic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525953

Locations
France
Centre Oscar LAMBRET
Lille, France, 59000
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Principal Investigator: Antoine ADENIS, MD, PhD Centre Oscar Lambret
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01525953     History of Changes
Other Study ID Numbers: CRCRT-EC
Study First Received: January 30, 2012
Last Updated: February 1, 2012
Health Authority: France: The Commission nationale de l’informatique et des libertés

Keywords provided by Centre Oscar Lambret:
esophageal cancer
radiochemotherapy
prognosis

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013