Colon cancer MedDRA version: 16.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Vigantol Oil
Product Name: Vigantol Oil (Cholecalciferol)
Product Code: n/a
Pharmaceutical Form: Oral liquid
INN or Proposed
Sponsors
Belfast HSC Trust
Queens University Belfast
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Over 200 new patients with bowel tumours present to the Belfast Trust each year. Approximately 240 patients will be invited to participate throughout the study interval to enable study completion with 120 patients. Inclusion criteria include patients aged 30-90 of either sex with a sporadic primary operable bowel tumour, presenting to the Belfast Hospitals Trust who have adequate kidney, liver and bone marrow function, Eastern cooperative oncology group (ECOG) performance status =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: Colitis-associated or hereditary colorectal cancer, hypercalcaemia, hyperparathyroidism, diabetes mellitus, steroid, anticoagulant or concurrent Vitamin D therapy, skeletal or liver metastases, ECG indication of recent myocardial instability, ECOG performance status >2.0, impairment of kidney or liver function evidenced by persistent elevation of serum urea and/or bilirubin, inability to obtain paired pre- and post-treatment tumour biopsies for analysis. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, are all exclusion criteria. Pregnant women are excluded from this study because effects of high dose Vit-D on the developing foetus are unknown. Failure of tissue sampling or other relevant methodology comprise exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Principal objective To assess effects of Vit-D levels that are known to suppress cancer on the concentration of a surrogate endpoint biomarker (SEB) called CYP27B1 in the bowel. CYP27B1 converts blood Vit-D into a more active form. ; Secondary Objective: Secondary objectives include (i) assessment of Vit-D treatment effects on other SEBs in normal bowel and (ii) bowel tumours. (iii) Investigation of relationships between SEBs and tumour aggressiveness, assessed in 3 grades under the microscope. (iv) Mutation in the K-ras gene can cause Vit-D resistance and will be investigated in bowel tumours. ; Primary end point(s): To test effects of cancer-suppressive serum Vit-D levels on CYP27B1 expression in the bowel. ;Timepoint(s) of evaluation of this end point: Expression of CYP27B1 in human colon. This will be assessed at three weeks after a single high dose of oral Vitamin D. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary objectives will assess (i) Expression, interrelationships and treatment effects on SEBs in normal mucosa (ii) SEB responses in CRC vs normal mucosa (iii) SEB associations with histopathological CRC prognostic factors (iv) Associations between CRC K-Ras genotype and SEB responses ;Timepoint(s) of evaluation of this end point: The above endpoints will be assessed at 3 weeks after a single high dose of Vitamin D. | — |
Countries
United Kingdom
Contacts
Public ContactProf Campbell
N. Ireland Cancer Trials Center
Outcome results
None listed