Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Oxford
With
oxBRC
Vodafone UK Foundation
Centre for Statistics in Medicine
Oncology Clinical Trials Office (OCTO, Oxford)
Patients with metastatic colorectal or breast cancer will be recruited.
* Metastatic Colorectal Cancer: capecitabine alone or capecitabine + oxaliplatin for 8 3-week cycles
* Metastatic Breast Cancer: capecitabine alone or capecitabine + docetaxel for 8 3-week cycles.
All patients will be given a mobile phone onto which they will enter any side-effects experienced prior to taking capecitabine in the morning and evening. Any grade 3 or 4 symptoms will trigger an alert to a pager held by the ward-staff for immediate attention. Thus, patients' severe side-effects will be monitored in real time and the trial will allow real-time dose reductions during cycles and dose-increases at clinics. Patient experience in the trial will also be evaluated during their participation in the trial.
Patients will already be receiving the drug prior to this study and will not be administered to patients as part of this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Metastatic colorectal or breast cancer patients commencing treatment on one of four specified regimens
For metastatic colorectal cancer:
capecitabine 2000mg/m2 d 1-14, q 3 weekly and oxaliplatin 130mg/m2 d1 q 3 weekly (CAPOX)
capecitabine 2500mg/m2 d 1-14, q 3 weekly
For metastatic breast cancer:
capecitabine 2000mg/m2d 1-14, q 3 weekly
capecitabine 2000mg/m2 d 1-14, q 3 weekly and docetaxel 75mg/m2 d1 q 3 weekly
Age \> 18 years
Fit to start at full (100%) starting dose of all drugs
Able and willing to use mobile phone
Reasonable renal, liver and bone marrow function
Absolute neutrophil count (ANC) \>1.5 x 109/L
Platelet count \> 100 x 109/L
Total bilirubin \<1.5 ULN
ALT, AST \< 2.5 x ULN
Alkaline phosphatase \< 2.5 x ULN
No obvious contra indications to capecitabine or oxaliplatin or docetaxel
Patients must also be able to read, write and understand English.
You may not be if
Patients who live in an area of no Vodafone or Orange mobile phone network - - Patients participating in other cancer treatment trials
Moderate or severe renal impairment \[creatinine clearance \<30ml/min (calculated according to Cockroft-Gault formula)\]