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 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT02071069
Eligibility Criteria:
Inclusion Criteria:
1. Patients aged ≥18 years with histologically confirmed metastatic colorectal cancer
2. Eastern Cooperative Oncology Group performance status ≤2 and
3. life expectancy of \>3 months were enrolled.
4. All patients had to have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1)
5. None was previous exposure to Cetuximab or irinotecan .
6. Patients had to have adequate haematological (absolute neutrophil count \>1.5 × 109/l; platelet count \>100 × 109/l; haemoglobin \>9 g/dl), hepatic \[total bilirubin \<1.5 × the upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase \<2.5 × ULN, or \<5 × ULN in the case of hepatic metastases or \<10 × ULN in the case of osseous metastases; alkaline phosphatase \<2.5 × ULN, or \<5 × ULN or \<10 × ULN in the case of hepatic or osseous metastases, respectively\] and renal function (creatinine clearance ≥60 ml/min)
7. All RAS were wildtype. -
Exclusion Criteria:
1. Pregnant or breast-feeding women;
2. Clinically significant cardiac disease;
3. Lack of physical integrity of the upper gastrointestinal tract;
4. History of other malignancy;
5. Central nervous system metastases. -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02071069
Study Brief:
Protocol Section:
NCT02071069