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Completed

NCT Number: NCT00911092

Predictive Proteomic Factors of the Response to Concomitant Radiochemotherapy in Esophageal 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.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre Paul Papin, Angers, France

Loading trial locations.

About this study

Further informations will be provided by Centre Oscar Lambret.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

blood sampling

Procedure

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

Chemotherapy (Fluorouracil and Cisplatin)

Drug

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 outcomes

  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 outcomes

  1. Prolonged clinical response at one year

    Time frame: One year after the end of irradiation

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Official study title

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

Acronym: COL06-13

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jun 1, 2009
Registry last updated
Jan 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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