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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT01552967
Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent;
* Patients with histologically or cytologically confirmed stage IV colorectal adenocarcinoma whose ECOG performance status are 0-2;
* Presence of measurable disease by radiographic study (including CT or MRI scan, or chest x-ray) or physical examination;
* At least 3 weeks since last major surgery;
* At least 12 months since last adjuvant chemotherapy;
* At least 6 weeks since prior radiotherapy providing that the extent and site of radiotherapy fields are such that marked bone marrow suppression is NOT expected;
* Patients who have received palliative radiotherapy must have recovered from any reversible toxic effects e.g. nausea and vomiting caused by radiation of fields;
* Patients with reproductive potential must use effective BC;
* Required Screening Laboratory Criteria:
* Hemoglobin 90g/L
* WBC 3.5 x 109/L
* Neutrophils 1.5 x 109/L
* Platelets 100 x 109/L
* Creatinine 133 umol/L and creatinine clearance 60 mL/min
* A probable life expectancy of at least 6 months;
Exclusion Criteria:
* Brain metastases;
* Female of childbearing potential, pregnancy test is positive;
* Concomitant malignancies or previous malignancies other than colorectal cancer within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or low grade prostate cancer;
* Active infection;
* Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk;
* Sexually active patients refusing to practice adequate contraception;
* Patients with conditions which might affect absorption of an oral drug (for example intermittent obstruction) unless discussed and agreed with principal investigator;
* History of grade 3 or 4 toxicity to fluoropyrimidines;
* Pre-existing neuropathy ≥ NCI CTC grade 2.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01552967
Study Brief:
Protocol Section:
NCT01552967