Predictive Proteomic Factors of the Response to Concomitant Radiochemotherapy in Esophageal Cancer (COL06-13)

December 30, 2011 updated by: Centre Oscar Lambret

Study of Predictive Proteomic Factors of the Response to Exclusive Concomitant Radiochemotherapy in Oesophageal Cancer

The scope of the trial is to predict the early complete clinical response to exclusive concomitant radiochemotherapy in esophageal cancer by the study of the pre- and per- therapeutic proteomic profile.

Study Overview

Status

Completed

Conditions

Esophageal Cancer

Intervention / Treatment

Detailed Description

Further informations will be provided by Centre Oscar Lambret.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Angers, France, 49933
    - Centre Paul Papin
  - Brest, France, 29200
    - Centre Hospitalier Universitaire
  - Caen, France, 14046
    - Centre Francois Baclesse
  - Lille, France, 59020
    - Centre Oscar Lambret
  - Rennes, France, 35042
    - Centre Eugène Marquis
  - Rouen, France, 76031
    - Chu - Hôpital Charles Nicolle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Invasive esophageal carcinoma at any stage (all T, N0 or N1, M0 or M1a), histologically proven
Treated by exclusive concomitant radiochemotherapy
Written informed consent

Exclusion Criteria:

Presence of a second uncontrolled cancer
Metastatic carcinoma
Metastatic disease, except cervical lymphnodes... (M1a)
In situ carcinoma
Eso-gastric junction cancer (Siewert II ou III)
Inclusion in a clinical trial with an experimental drug during the study and until 15 weeks after the end of radiotherapy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proteomic analysis by Protein-Chip Technology of Ciphergen and mass spectrometry Time Frame: 15 weeks after the end of irradiation	15 weeks after the end of irradiation
Initial complete clinical response Time Frame: 15 weeks after the end of irradiation	15 weeks after the end of irradiation

Secondary Outcome Measures

Outcome Measure	Time Frame
Prolonged clinical response at one year Time Frame: One year after the end of irradiation	One year after the end of irradiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Investigators

Principal Investigator: ADENIS Antoine, MD, PhD, Centre Oscar Lambret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

May 29, 2009

First Submitted That Met QC Criteria