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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-12-31

Brief Summary

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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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Detailed Description

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Further informations will be provided by Centre Oscar Lambret.

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Blood sampling

Before any study treatment, 14 days after radiotherapy, 15 weeks after radiotherapy

Intervention Type PROCEDURE

Radiation

Week 1 to week 5-6 1.8-2 Gys/fraction, 5 days a week for a total of 5 to 6 weeks

Intervention Type RADIATION

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No