Colorectal cancer Cancer Malignant neoplasm of other and ill-defined digestive organs
Conditions
Interventions
A randomised crossover clinical trial comparing bolus fluorouracil/leucovorin to capecitabine
Sponsors
University of Leeds (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 18 years or above with 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) OR full resection of recurrent/metastatic colorectal cancer, if the patient was not previously treated with adjuvant chemotherapy.
Exclusion criteria
Exclusion criteria: Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient preference for one of two regimens 12 weeks after randomisation, when the patient will have experienced both regimens | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient preference at 12 weeks, after experiencing both regimens, according to treatment sequence 2. Toxicity - maximum NCIC grade toxicity experienced within first cycle of regimen 3. Quality of Life (QoL) - assessed at baseline, 6, 12 and 24 weeks post-randomisation. Assessed using EORTC QLQ-C30. 4. Dose intensity (DI) - delivered DI as a percentage of planned DI 5. Safety - comparison of rates of SAEs and SUSARS between the two regimens | — |
Countries
United Kingdom
Outcome results
None listed