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

NCT00911092 | Completed Phase 4

• 1 other identifier: 2006-13
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

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.

Conditions

Esophageal Cancer

Keywords

Oesophageal cancer; exclusive concomitant radiochemotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Prolonged clinical response at one year

  One year after the end of irradiation

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Invasive esophageal carcinoma at any stage (all T, N0 or N1, M0 or M1a), histologically proven
• Treated by exclusive concomitant radiochemotherapy
• Written informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Oscar Lambret: lead

Study Sites (6)

Centre Paul Papin

Angers, 49933, France

Location

Centre Hospitalier Universitaire

Brest, 29200, France

Location

Centre François BACLESSE

Caen, 14046, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

CHU - Hopital Charles Nicolle

Rouen, 76031, France

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Blood Specimen Collection; Radiation; Drug Therapy; Fluorouracil; Cisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Physical Phenomena; Therapeutics; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• ADENIS Antoine, MD, PhD

  Centre Oscar Lambret

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2009
• First Posted: June 1, 2009
• Study Start: October 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 2, 2012

Record last verified: 2011-12

Locations

FR (6)