Moderate to high risk resected colorectal cancer
Conditions
Interventions
Trade Name: Xeloda
Product Name: Xeloda
Pharmaceutical Form: Tablet
INN or Proposed INN: capecitabine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
INN or Pr
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patients over the age of 18 •Written informed consent obtained. •Clinical indication for colorectal adjuvant chemotherapy i.e.: o Dukes’ stage C or B colonic or rectal carcinoma, primary fully macroscopically resected (R0 or R1 resection), with no radiological or clinical evidence of metastatic disease (for Dukes’ B patients there must be a clinical indication for adjuvant chemotherapy, based on histological risk factors and patient factors). o or full resection of recurrent/metastatic colorectal cancer, if the patient was not previously treated with adjuvant chemotherapy. •Ready to start adjuvant therapy within 12 weeks of cancer resection •WHO performance status (PS) 0, 1 or 2, and considered by responsible consultant to be fit to undergo either of the possible treatment schedules. •Baseline laboratory tests (within 1 week prior to randomisation): o WBC > 3 x109/l and platelet count >100 x109/l o serum bilirubin = 1.25 x upper limit of normal (ULN), and serum transaminase (either AST or ALT) = 2.5 x ULN o either estimated creatinine clearance (Cockroft; page 29) >50ml/min or measured GFR (EDTA clearance) >50 ml/min. •For women of childbearing potential, negative pregnancy test and adequate contraceptive precautions. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •patients planned to receive postoperative radiotherapy or chemoradiotherapy (NB preoperative short-course radiotherapy is not a contraindication) •severe uncontrolled concurrent medical illness (e.g. poorly-controlled angina, CCF; MI within preceding 3 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 •Patients with another cancer within the preceding 3 years •Pregnant or Lactating females •Patients requiring ongoing treatment with a contraindicated concomitant medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary endpoint is patient preference for one of two regimens 12 weeks after randomisation, when the patient will have experienced both regimens;Secondary Objective: •Patient preference at 12 weeks, after experiencing both regimens, according to treatment sequence •Toxicity – maximum NCIC grade toxicity experienced within first cycle of regimen •Quality of Life (QoL) - assessed at baseline, 6, 12 and 24 weeks post-randomisation. Assessed using EORTC QLQ-C30 •Dose intensity (DI) – delivered DI as a percentage of planned DI •Safety – comparison of rates of SAEs and SUSARS between the two regimens ;Primary end point(s): The primary endpoint is patient preference for one of two regimens 12 weeks after randomisation, when the patient will have experienced both regimens | — |
Countries
United Kingdom
Outcome results
None listed