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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00911092

Acronym

COL

Enrollment

Registered

2009-06-01

Start date

2007-10-01

Completion date

2011-12-01

Last updated

2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

Oesophageal cancer, exclusive concomitant radiochemotherapy

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.

Detailed description

Further informations will be provided by Centre Oscar Lambret.

Interventions

PROCEDUREBlood sampling

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

DRUGChemotherapy (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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Proteomic analysis by Protein-Chip Technology of Ciphergen and mass spectrometry	15 weeks after the end of irradiation
Initial complete clinical response	15 weeks after the end of irradiation

Secondary

Measure	Time frame
Prolonged clinical response at one year	One year after the end of irradiation

Countries

France

Contacts

PRINCIPAL_INVESTIGATORADENIS Antoine, MD, PhD

Centre Oscar Lambret

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026