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 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT00209703
Eligibility Criteria:
Inclusion Criteria:
1. Histological diagnosis of colorectral adenocarcinoma.
2. Measurable or assessable lesions.
3. Age: 15 \~ 75 years.
4. Performance Status (ECOG): 0 \~ 2.
5. Prior chemotherapy within 2 regimens.
6. Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 3.0mg/dl. Creatinine within the upper limit of normal. Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes).
(10) Predicted survival for \>8 weeks. (11) Able to give written informed consent.
Exclusion Criteria:
1. Severe pleural effusion or ascites.
2. Metastasis to the central nervous system (CNS).
3. Active gastrointestinal bleeding.
4. Active infection.
5. Uncontrolled ischemic heart disease.
6. Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
7. Active multiple cancer.
8. Severe mental disorder.
9. Pregnancy, possible pregnancy, or breast-feeding.
10. Patients with neuropathy ≥ grade 2
11. Judged to be ineligible for this protocol by the attending physician.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
75 Years
Study:
NCT00209703
Study Brief:
Protocol Section:
NCT00209703