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 @ 2:48 AM
Ignite Modification Date:
2025-12-25 @ 2:48 AM
NCT ID:
NCT02484833
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven diagnosis of colorectal adenocarcinoma
* Diagnosis of metastatic disease
* RAS and BRAF wildtype
* Measurable disease according to RECIST criteria v1.1
* Male or female over 18 years of age
* ECOG Performance Status 2
* Life expectancy of at least 3 months
* Adequate bone marrow, liver and renal function assessed within 14 days before starting study treatment
* If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment
* If female and of childbearing potential, or if male, agreement to use adequate contraception
* Signed informed consent obtained at screening
Exclusion Criteria:
* Any contraindication to use cetuximab, irinotecan, 5 FU or folinic acid
* Active uncontrolled infections or active disseminated intravascular coagulation
* Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix
* Pregnancy.
* Breastfeeding.
* Grade III or IV heart failure (NYHA classification)
* Myocardial infarction, unstable angina pectoris, balloon angioplasty (PTCA) with or without stenting within the past 12 months before inclusion in the study
* Cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin
* Medical or psychological impairments associated with restricted ability to give consent or not allowing conduct of the study
* Previous chemotherapy for colorectal cancer with the exception of adjuvant treatment, completed at least 6 months before entering the study
* Participation in a clinical study or experimental drug treatment within 30 days prior to study inclusion or during participation in the study
* Known or clinically suspected brain metastases
* History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhoea
* Severe, non-healing wounds, ulcers or bone fractures
* Uncontrolled hypertension
* Marked proteinuria (nephrotic syndrome)
* Known DPD deficiency (specific screening not required)
* Known history of alcohol or drug abuse
* A significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study
* Absent or restricted legal capacity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02484833
Study Brief:
Protocol Section:
NCT02484833