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 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT03524820
Eligibility Criteria:
Inclusion Criteria:
* Men and women over 18
* Tissue diagnosis of metastatic colon cancer without operational or radiation therapy options
* No RAS mutation in tumor tissue
* Measurable disease according to RACIST criteria v1.1
* ECOG ( Eastern Cooperative Oncology Group) performance status \<=2
* Life expectancy of over 3 months
* Women of fertility age not pregnant
* Ability to understand and sign and informed consent form to participate in the trial and the ability to perform the treatment and follow up required for participation in the trial
* At least three months progression free time in first line cetuximab treatment
* Disease progression according to RACIST v1.1 for first and second lines
* Third line treatment will be applied no less then 17 weeks following and of first line treatment
Exclusion Criteria:
* RAS mutation carriers, or patients with uncertain metastatic colon cancer diagnosis
* Patients operated two weeks prior to accepting trail drug, or that did not recover from treatment
* Level 3 allergic response to any of trial drugs
* First line cetuximab treatment stopped due to allergic response
* Severe medical or mental diagnosis which might increase the risk in drug administration according to treating physician's discretion
* Pregnant or lactating women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT03524820
Study Brief:
Protocol Section:
NCT03524820