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 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT03254394
Eligibility Criteria:
Inclusion Criteria:
* Stage III and IV colorectal cancer.
* Scheduled for oxaliplatin treatment in mFOLFOX6-based chemotherapy regimen.
* Able to understand and willing to sign an IRB-approved written informed consent document.
Exclusion Criteria:
* Renal insufficiency (defined as calculated Creatinine clearance \< 30mL/min)
* Moderate to severe liver failure (defined as ALT or AST \> 3 times upper limit of normal if no liver metastases are present; ALT or AST \> 5 times upper limit of normal if liver metastases are present).
* Presence of brain metastases.
* Patients with currently uncontrolled cardiac arrhythmias (non-sinus rhythm).
* Patients with history of arrhythmias under pharmacological/pacemaker control will be allowed, except if receiving antiarrhythmic medication listed in "contra-indicated medications".
* Contraindication or allergy to intravenous lidocaine.
* Pre-existing symmetric peripheral painful neuropathy.
* Treated with chemotherapy within the past 12 months.
* Pregnancy or breastfeeding
* Currently treated with any of the following contraindicated medications: Saquinavir, Lopinavir, Amprenavir, Atazanavir, Delavirdine, Mexiletine (and other types of sodium-channel blocker antiarrhythmics), Phenytoin, Carbamazepine, Oxcarbazepine, Lamotrigine, Amiodarone, Dronedarone, Dihydroergotamine, Cimetidine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03254394
Study Brief:
Protocol Section:
NCT03254394