Know Cancer

forgot password

Toxicity OF Fluoropyrimidines: A Comparative Study of the Cardiotoxicity of capEcitabine and tEysuno

Phase 2
18 Years
Not Enrolling
Gastrointestinal Cancer

Thank you

Trial Information

Toxicity OF Fluoropyrimidines: A Comparative Study of the Cardiotoxicity of capEcitabine and tEysuno

Inclusion Criteria:

- 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
contraceptive precautions.

- Effective contraception for male patients if the risk of conception exists.

- Written informed consent for participation in the trial.

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary endpoint of the study will be a difference in the duration of ST deviation pre-treatment and during treatment.

Outcome Description:

This will be recorded using Del Mar Reynolds Lifecard CF/Lifecard 12 recorders, which will record 12 leads over 24 hours and continuously if the storage card is changed daily. Pre-treatment control ECGs will be recorded for 24 hours. Continuous 12-lead monitoring shall be recorded for three days between day 5 and 7 of treatment.

Outcome Time Frame:

Pre treatment and between day 5-7

Safety Issue:


Principal Investigator

Sally Clive, MBChB

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Edinburgh


United Kingdom: Research Ethics Committee

Study ID:




Start Date:

June 2013

Completion Date:

Related Keywords:

  • Gastrointestinal Cancer
  • Gastrointestinal Neoplasms