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:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT00884767
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed colorectal cancer
* Requires treatment with oxaliplatin (as part of a FOLFOX regimen)
* No brain metastases or symptomatic meningitis
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* Life expectancy \> 3 months
* ANC ≥ 1 x 10\^9/L
* Platelet count ≥ 100 x 10\^9/L
* Total bilirubin ≤ 2 times upper limit of normal (ULN)
* Transaminases ≤ 3 times ULN
* Alkaline phosphatase ≤ 5 times ULN
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No prior or concurrent clinical neuropathy (regardless of the etiology)
* No dihydropyrimidine dehydrogenase deficiency
* No psychiatric illness that would preclude comprehension of the study or of the informed consent
* No other severe illness that may worsen during treatment, including unstable cardiac disease, myocardial infarction within the past 6 months, or active uncontrolled infection
* No psychological, social, familial, or geographical reason that would preclude study follow-up
* Other cancer within the past 5 years allowed provided treatment did not include platinum derivatives or taxanes
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Prior chemotherapy allowed (except for platinum derivatives or taxanes)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00884767
Study Brief:
Protocol Section:
NCT00884767