PACT (Patient Preferences in Adjuvant Colorectal Cancer Therapy): a randomised crossover clinical trial comparing bolus fluorouracil/leucovorin to capecitabine as treatment for moderate to high risk resected colorectal cancer
Not Applicable
Completed
- Conditions
- Colorectal cancerCancerMalignant neoplasm of other and ill-defined digestive organs
- Registration Number
- ISRCTN35708246
- Lead Sponsor
- niversity of Leeds (UK)
- Brief Summary
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18612156
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 74
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
Does not meet inclusion criteria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient preference for one of two regimens 12 weeks after randomisation, when the patient will have experienced both regimens
- Secondary Outcome Measures
Name Time Method 1. Patient preference at 12 weeks, after experiencing both regimens, according to treatment sequence<br>2. Toxicity - maximum NCIC grade toxicity experienced within first cycle of regimen<br>3. Quality of Life (QoL) - assessed at baseline, 6, 12 and 24 weeks post-randomisation. Assessed using EORTC QLQ-C30.<br>4. Dose intensity (DI) - delivered DI as a percentage of planned DI<br>5. Safety - comparison of rates of SAEs and SUSARS between the two regimens