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 @ 1:38 PM
Ignite Modification Date:
2025-12-24 @ 1:38 PM
NCT ID:
NCT00004195
Eligibility Criteria:
Inclusion:
1. DISEASE CHARACTERISTICS: Histologically proven or suspicious primary or metastatic colorectal carcinoma undergoing disease resection
2. PATIENT CHARACTERISTICS:A. Age: 19 and over
3. Performance status: Karnofsky 60-100%
4. Not pregnant or nursing Fertile patients must use effective contraception during and for at least 1 month after study
5. PRIOR CONCURRENT THERAPY:
6. Subject has had at least 8 weeks since prior fluorouracil, capecitabine, fluorouracil-uracil, floxuridine, or S-1 Endocrine therapy:
7. No prior or concurrent steroids Radiotherapy:
8. Surgery: No prior emergent surgery (e.g., perforation or obstruction) No prior transplantation
9. At least 8 weeks since any prior drug metabolized by dihydropyrimidine dehydrogenase enzyme At least 8 weeks since prior flucytosine
Exclusion:
1. Severe infection(White Blood Cell Count)WBC\>2 times normal
2. Fever
3. Sepsis
4. Subject on immunosuppressives therapy
5. Subjects will serum Bilirubin/Creatinine\>2 times normal levels
6. Pregnant /Lactating women
7. Subjects that have received eniluracil or 5-FU(Fluorouracil) within 28 days prior to randomization
8. Subject that have comorbidity illnesses that will increase the likelihood of there death in \<5 years
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
80 Years
Study:
NCT00004195
Study Brief:
Protocol Section:
NCT00004195