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 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT03562234
Eligibility Criteria:
Inclusion Criteria:
1. Histologically verified adenocarcinoma of the colon or rectum with radiological evidence of potentially resectable liver metastases, with no evidence of unresectable non-hepatic metastatic disease.
2. Pre-operative chemotherapy planned using Oxaliplatin-based chemotherapy regimen (including FOLFOX, XELOX and OXCAP regimens
3. Age greater than or equal to 18 years
4. WHO (World Health Organisation) performance status 0, 1 or 2
5. Adequate haematological and hepatic function defined by: Hb ³ 10g/dl, WBC ³ 3.0 x 109/L, ANC ³ 1.5 x 109/L, platelet count ³ 100,000/ mm3, total bilirubin \< 30 mmol/L, serum AST, ALT and alkaline phosphatase 5 x upper limit of normal
6. Renal function with creatinine clearance 60 mls/min (for full dose) or 30 ml/min for 50%-dose oxaliplatin
7. Patients must have given written informed consent
8. Any woman of childbearing potential must have a negative pregnancy test prior to enrolment in to the study and must take adequate precautions to prevent pregnancy during treatment
Exclusion Criteria:
1. Presence of a medical or psychiatric condition that impairs their ability to give informed consent
2. Presence of any other serious uncontrolled medical conditions
3. Evidence of unresectable non-hepatic metastatic disease
4. Pregnant or lactating women. Adequate contraception must be used in fertile patients
5. Contra-indications to MR scanning
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03562234
Study Brief:
Protocol Section:
NCT03562234