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

This study has been completed.
Information provided by (Responsible Party):
Centre Oscar Lambret Identifier:
First received: May 29, 2009
Last updated: December 30, 2011
Last verified: December 2011
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.

Condition Intervention Phase
Esophageal Cancer Procedure: Blood sampling Radiation: Radiation Drug: Chemotherapy (Fluorouracil and Cisplatin) Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Study of Predictive Proteomic Factors of the Response to Exclusive Concomitant Radiochemotherapy in Oesophageal Cancer

Resource links provided by NLM:

Further study details as provided by Centre Oscar Lambret:

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

Secondary Outcome Measures:
  • Prolonged clinical response at one year [ Time Frame: One year after the end of irradiation ]

Enrollment: 50
Study Start Date: October 2007
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Blood sampling
    Before any study treatment, 14 days after radiotherapy, 15 weeks after radiotherapy
    Radiation: Radiation
    Week 1 to week 5-6 1.8-2 Gys/fraction, 5 days a week for a total of 5 to 6 weeks
    Drug: Chemotherapy (Fluorouracil and Cisplatin)

    At weeks 1, 5, 8 and 11

    • Day 1 to day 4: Fluorouracil 1 gr/m²/day
    • Day 1 or 2: Cisplatin 75 mg/m²
Detailed Description:
Further informations will be provided by Centre Oscar Lambret.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00911092

Centre Paul Papin
Angers, France, 49933
Centre Hospitalier Universitaire
Brest, France, 29200
Centre François BACLESSE
Caen, France, 14046
Centre Oscar Lambret
Lille, France, 59020
Centre Eugène Marquis
Rennes, France, 35042
CHU - Hopital Charles Nicolle
Rouen, France, 76031
Sponsors and Collaborators
Centre Oscar Lambret
Principal Investigator: ADENIS Antoine, MD, PhD Centre Oscar Lambret
  More Information

Responsible Party: Centre Oscar Lambret Identifier: NCT00911092     History of Changes
Obsolete Identifiers: NCT00932815
Other Study ID Numbers: 2006-13
Study First Received: May 29, 2009
Last Updated: December 30, 2011

Keywords provided by Centre Oscar Lambret:
Oesophageal cancer
exclusive concomitant radiochemotherapy

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on September 19, 2017