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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT00911092
First received: May 29, 2009
Last updated: December 30, 2011
Last verified: December 2011
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Study of Predictive Proteomic Factors of the Response to Exclusive Concomitant Radiochemotherapy in Oesophageal Cancer

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
  • Initial complete clinical response [ Time Frame: 15 weeks after the end of irradiation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prolonged clinical response at one year [ Time Frame: One year after the end of irradiation ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00911092

Locations
France
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
Investigators
Principal Investigator: ADENIS Antoine, MD, PhD Centre Oscar Lambret
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov 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
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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
Cisplatin
Fluorouracil
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on June 18, 2013