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 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 12:09 AM
NCT ID:
NCT01282658
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed colorectal cancer
2. ≥ 18 years old
3. Measurable disease, defined as to RECIST criteria
4. Unresectable metastatic disease OR First recurrence/metastasis after adjuvant therapy and not suitable for operation
5. FOLFIRI±cetuximab/bevacizumab as the first-line therapy
6. Without expected course of radiotherapy during the first-line chemotherapy
7. No previous CPT-11 chemotherapy
8. ECOG performance status (PS) 0-2
9. Not pregnant or nursing and Negative pregnancy test
10. Voluntarily signed the informed consent
11. Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
12. AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN if f liver metastases present)
13. Creatinine clearance \> 50 mL/min OR serum creatinine ≤ 1.5 times ULN
Exclusion Criteria:
1. Brain metastases with obvious symptoms
2. Severe bone marrow failure and can not be corrected
3. Chronic diarrhea history
4. Bowel obstruction without control
5. Mental illness without control
6. Clinically significant (i.e., active) cardiovascular disease, including any of the following: Cerebrovascular accidents/ Myocardial infarction/ Unstable angina/ New York Heart Association class II-IV congestive heart failure/ Serious cardiac arrhythmia requiring medication/ Uncontrolled hypertension
7. Other co-existing malignancy or malignancy diagnosed within the past 5 years, except for basal cell or squamous cell carcinoma, or carcinoma in situ of the cervix
8. Pelvic radiotherapy for the past 1 year
9. Known allergy to any of the components of the study medications
10. Serious, nonhealing wound or ulcer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01282658
Study Brief:
Protocol Section:
NCT01282658