- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01448759
Evaluation of Plasma Alcohol Concentration in Patients Receiving Paclitaxel or Docetaxel (ALCOOTAX)
April 23, 2015 updated by: Institut Curie
Prospective Evaluation of Plasma Alcohol Concentration in Patients Receiving Paclitaxel or Docetaxel Infusion
The purpose of this study is to evaluate plasma alcohol concentration in patients receiving Paclitaxel or Docetaxel infusion.
Study Overview
Detailed Description
In this study, there is no experimental treatment, or experimental care.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Paris, France, 75005
- Institut Curie
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Chemotherapy with docetaxel or paclitaxel on an every 3-week schedule.
- Patient with bitherapy are eligible only if the taxane is the first infusion.
- All type of tumor.
- Age>18 years old.
- Signed written informed consent.
Exclusion Criteria:
- Patient under 18.
- Patient with bitherapy, if docetaxel or paclitaxel is not administered first.
- Patient deprived of liberty.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of plasma alcohol
Time Frame: One year
|
Measure of the plasma alcohol level before and after a taxane-based therapy (docetaxel or paclitaxel)
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: LE TOURNEAU Christophe, MD, Institut Curie
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
October 6, 2011
First Submitted That Met QC Criteria
October 6, 2011
First Posted (Estimate)
October 7, 2011
Study Record Updates
Last Update Posted (Estimate)
April 24, 2015
Last Update Submitted That Met QC Criteria
April 23, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- IC 2011-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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