|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00911092 |
|
Date of registration:
|
29/05/2009 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Predictive Proteomic Factors of the Response to Concomitant Radiochemotherapy in Esophageal Cancer
COL06-13 |
|
Scientific title:
|
Study of Predictive Proteomic Factors of the Response to Exclusive Concomitant Radiochemotherapy in Oesophageal Cancer |
|
Date of first enrolment:
|
October 2007 |
|
Target sample size:
|
50 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00911092 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
ADENIS Antoine, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Centre Oscar Lambret |
| | |
|
Key inclusion & exclusion criteria
|
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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Esophageal Cancer
|
|
Intervention(s)
|
|
Drug: Chemotherapy (Fluorouracil and Cisplatin)
|
|
Procedure: Blood sampling
|
|
Radiation: Radiation
|
|
Primary Outcome(s)
|
|
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 Outcome(s)
|
|
Prolonged clinical response at one year
[Time Frame: One year after the end of irradiation]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|