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

Centre Oscar Lambret50 enrolled

Overview

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.

Further informations will be provided by Centre Oscar Lambret.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Esophageal Cancer

Interventions

Blood samplingPROCEDURE

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

RadiationRADIATION

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (6)

Centre Paul Papin

Angers, France

Centre Hospitalier Universitaire

Brest, France

Centre François BACLESSE

Caen, France

Centre Oscar Lambret

Lille, France

Outcomes

Primary Outcomes

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 Outcomes

Prolonged clinical response at one year

Time frame: One year after the end of irradiation

Data from ClinicalTrials.gov

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