Toxicity OF Fluoropyrimidines: A Comparative Study of the Cardiotoxicity of capEcitabine and tEysuno
- Male or female patients at least 18 years or over with no upper age limit.
- Confirmed advanced or metastatic oesophageal, gastric, gastro-oesophageal, small
bowel, colorectal, hepatobiliary or pancreatic cancer.
- Suitable for treatment with fluoropyrimidine, either alone or in combination with
- WHO performance status (PS) 0, 1 or 2 and considered by responsible consultant to be
fit to undergo planned chemotherapy and cardiac investigations.
- Baseline laboratory tests (within 1 week prior to starting treatment):
- Neutrophils >1.5 x109 /L and platelet count > 100 x109 /L
- Serum bilirubin <3 x upper limit of normal (ULN), alkaline phosphatase <5x ULN,
and serum transaminase (either AST or ALT) <5 x ULN
- Estimated creatinine clearance >50 mL/min (Cockcroft and Gault, adjusted for
BSA; Appendix ?) or estimated glomerular filtration rate (eGFR) >50 mL/min.
[Patients with Cr Cl 30-50 mL/min will be included but should be treated at a
reduced dose (see master prescription chart)]
- For women of childbearing potential; negative pregnancy test and adequate
- Effective contraception for male patients if the risk of conception exists.
- Written informed consent for participation in the trial.
- Patients who are unfit for the chemotherapy regimens in this protocol, such as:
- Known intolerance to CAP or other FPs
- Severe uncontrolled concurrent medical illness likely to interfere with protocol
- Poorly controlled angina or MI in previous 6 months
- Any psychiatric or neurological condition which is felt likely to compromise the
patient's ability to give informed consent or to comply with oral medication
- Partial or complete bowel obstruction
- Pre-existing neuropathy > grade 1 if combination therapy proposed
- Patients on therapeutic anticoagulation (warfarin or LMWH).
- Patients unable to lie flat.
- Patients unable to withstand the visits and cardiovascular investigations proposed
within the study.