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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT00327093
Eligibility Criteria:
Inclusion Criteria:
* Patients \>= 18 years old
* Patients with colon or rectal carcinoma histologically proven
* Patients with metastases (synchronous or metachronous)
* Patients with associated extra-hepatic disease (asymptomatic primary tumor or extra-hepatic metastases)
* Performance status (World Health Organization \[WHO\]) = 0, 1, or 2
* Life expectancy \>= 3 months
* Patients with normal haematological, kidney, and liver parameters (PNN \> 1.5 x 10\^9/L, platelets \> 100 10\^9/L, total bilirubin \<= 1.25 x upper limit of normal (ULN), ASAT/ALAT \<= 5 x ULN, creatinaemia \<= 135 µmol/L (1.5 mg/dL)
* No cardiac or coronary insufficiency untreated
* At least 4 weeks between surgery and study beginning
* Patients can have a biopsy of the hepatic lesion identified by ultrasound.
* Informed consent signed.
Exclusion Criteria:
* Patients with symptomatic tumors (colon or rectal)
* Patients with others tumors not cured
* Patients who cannot be treated by 5-fluorouracil (5-FU) and/or irinotecan because of special medical conditions or other serious disease.
* Patients who participated in another clinical trial since less than 30 days
* Pregnancy or breast-feeding women
* Patients who cannot be treated because of active infection or other serious disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00327093
Study Brief:
Protocol Section:
NCT00327093