COL06-13: Predictive Proteomic Factors of the Response to Concomitant Radiochemotherapy in Esophageal Cancer

• Sponsor: Centre Oscar Lambret (Other)
• Overall Status: Completed
• CT.gov ID: NCT00911092
• Collaborator: (none)
• Enrollment: 50
• Locations: 6
• Duration (Months): 50
• Patients Per Site: 8.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Procedure: Blood sampling; Radiation: Radiation; Drug: Chemotherapy (Fluorouracil and Cisplatin)	Phase 4

Detailed Description

Further informations will be provided by Centre Oscar Lambret.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Study of Predictive Proteomic Factors of the Response to Exclusive Concomitant Radiochemotherapy in Oesophageal Cancer
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Outcome Measures

Primary Outcome Measures

1. Proteomic analysis by Protein-Chip Technology of Ciphergen and mass spectrometry [15 weeks after the end of irradiation]

2. Initial complete clinical response [15 weeks after the end of irradiation]

Secondary Outcome Measures

1. Prolonged clinical response at one year [One year after the end of irradiation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Paul Papin	Angers		France	49933
2	Centre Hospitalier Universitaire	Brest		France	29200
3	Centre François BACLESSE	Caen		France	14046
4	Centre Oscar Lambret	Lille		France	59020
5	Centre Eugène Marquis	Rennes		France	35042
6	CHU - Hopital Charles Nicolle	Rouen		France	76031

Sponsors and Collaborators

• Centre Oscar Lambret

Investigators

• Principal Investigator: ADENIS Antoine, MD, PhD, Centre Oscar Lambret

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Oscar Lambret
• ClinicalTrials.gov Identifier: NCT00911092
• Other Study ID Numbers: 2006-13; NCT00932815
• First Posted: Jun 1, 2009
• Last Update Posted: Jan 2, 2012
• Last Verified: Dec 1, 2011

• Keywords provided by Centre Oscar Lambret: Oesophageal cancer; exclusive concomitant radiochemotherapy
• Additional relevant MeSH terms: Esophageal Neoplasms; Fluorouracil

Study Results

No Results Posted as of Jan 2, 2012