Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT00272051
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically proven adenocarcinoma of the colon or the rectum
* age \> 18 years
* WHO performance status : 0,1,2
* Signed written informed consent prior to study entry
* Disease stage : metastatic disease not amenable to potentially curative treatment (eg : inoperable metastatic disease)
* Measurable disease
* No prior chemotherapeutic regimen for metastatic disease ; prior adjuvant chemotherapy allowed (disease free interval from end of adjuvant therapy of at least 6 months)
* Prior radiotherapy permitted, if completed at least 3 weeks before randomization, and if not administered to target lesions identified for the study
Exclusion Criteria:
* Chemotherapeutic agents other than 5-FU/LV or 5-FU/Levamizole as part of adjuvant therapy
* Prior therapy with Oxaliplatin
* History of cardiac toxicities under 5-FU/LV therapy or myocardial infarction within the 6 months before study entry ; Known Dihydropyrimidine Dehydrogenase deficiency
* History of intolerance to appropriate antiemetics
* Concurrent active cancer originating from a primary site other than colon or rectum
* Presence of any symptom suggesting brain metastasis
* Known peripheral neuropathy
* Interstitial pneumonia or extensive and symptomatic fibrosis of the lung
* Allergy to Xaliproden/excipients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00272051
Study Brief:
Protocol Section:
NCT00272051