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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00911092
Recruitment Status : Completed
First Posted : June 1, 2009
Last Update Posted : January 2, 2012
Information provided by (Responsible Party):
Centre Oscar Lambret

Brief Summary:
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 or disease Intervention/treatment Phase
Esophageal Cancer Procedure: Blood sampling Radiation: Radiation Drug: Chemotherapy (Fluorouracil and Cisplatin) Phase 4

Detailed Description:
Further informations will be provided by Centre Oscar Lambret.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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
Study Start Date : October 2007
Actual Primary Completion Date : September 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00911092

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

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Responsible Party: Centre Oscar Lambret Identifier: NCT00911092     History of Changes
Obsolete Identifiers: NCT00932815
Other Study ID Numbers: 2006-13
First Posted: June 1, 2009    Key Record Dates
Last Update Posted: January 2, 2012
Last Verified: December 2011
Keywords provided by Centre Oscar Lambret:
Oesophageal cancer
exclusive concomitant radiochemotherapy
Additional relevant MeSH terms:
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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