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

Esophageal Cancer Clinical Trial

— COL06-13  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911092
• Other study ID #: 2006-13
• Status: Completed
• Phase: Phase 4
• First received: May 29, 2009
• Last updated: December 30, 2011
• Start date: October 2007
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Description:

Further informations will be provided by Centre Oscar Lambret.

Other known NCT identifiers

• NCT00932815

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Centre Paul Papin	Angers
France	Centre Hospitalier Universitaire	Brest
France	Centre François BACLESSE	Caen
France	Centre Oscar Lambret	Lille
France	Centre Eugène Marquis	Rennes
France	CHU - Hopital Charles Nicolle	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proteomic analysis by Protein-Chip Technology of Ciphergen and mass spectrometry		15 weeks after the end of irradiation	No
Primary	Initial complete clinical response		15 weeks after the end of irradiation	No
Secondary	Prolonged clinical response at one year		One year after the end of irradiation	No