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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT03391934
Eligibility Criteria:
Inclusion Criteria:
* Male or female older than 18 years old
* Histologically confirmed adenocarcinoma of the colon or rectum which is metastatic
* Having one or more bi-dimensionally measurable lesions as defined by RECIST criteria
* Tumor that could not be resected for curative purposes
* ECOG performance status score of 2 or less
* Life expectancy of longer than 3 months (clinical assessment)
* Evidence of tumor EGFR expression (expanded wild-type RAS)
* Adequate organ and marrow function as defined:
ANC ≥ 1,500/mm3 Plt ≥ 100,000/mm3 Hb ≥ 9 g/dL (may have had blood transfusions) AST/ALT ≤ 2.5 IULN or ≤ 5 IULN with known liver metastases Total bilirubin ≤ 1.5 IULN Serum Creatinine ≤ 1.5 IULN INR ≤ 1.5 and PTT ≤ 1.5 IULN
Exclusion Criteria:
* Previous exposure to an anti-EGFR therapy or irinotecan-based chemotherapy
* Radiotherapy, surgery (excluding previous diagnostic biopsy), or any investigational drug in the 30-day period before the start of treatment in our trial
* Female patients who are pregnant or lactating
* Patients with any history of another primary malignancy in the past five years, with the exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix
* Patients with history of allergic reactions attributed to compounds of similar chemical or biologic drugs as cetuximab, irinotecan, fluorouracil or leucovorin
* Adjuvant treatment that was terminated 6 months or less before the start of treatment in our trial
* Inability to comply with study and/or follow-up procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03391934
Study Brief:
Protocol Section:
NCT03391934