Topic: National Cancer Research Network
Conditions
Interventions
1. FU: In cohort I, patients receive 5FU in weeks 1 and 4 as a continuous infusion for 5 days (total of 10 days) concurrently with radiotherapy 2. Cetuximab, Loading dose given in week before start of
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 or over 2. Histologically proven invasive bladder carcinoma [adenocarcinoma, transitional cell carcinoma (TCC) or squamous cell carcinoma (SCC)] 3. Localised muscle invasive carcinoma either surgically or by imaging (T2-T4a N0 M0) 4. World Health Organisation (WHO) performance status grade 0 to 1 5. Adequate haematological function (haemoglobin > 10g/dl; white blood cells (WBC) > 3.0x109/L; absolute neutrophils count (ANC) > 1.5x109/L; platelet count > 100,000/mm3) 6. Adequate hepatic function {billirubin 40 ml/min [by ethylenediamine tetraacetic acid (EDTA) clearance, 24h urine collection, or Cockcroft-Gault] 8. Available for long-term follow-up 9. Able to receive a radical course of radiotherapy 10. Patient?s written informed consent 11. Have received 3-4 cycles of neo-adjuvant chemotherapy (preferably Gemcitabine/Cisplatin) with a positive response (confirmed by cystoscopy & radiological response) with pre neo-adjuvant imaging computerised tomography (CT) scan or magnetic resonance imaging (MRI) of abdomen and pelvis.; Target Gender: Male & Female ; Lower Age Limit 18 years
Exclusion criteria
Exclusion criteria: 1. Uncontrolled systemic disease which would preclude the patient from participating in the study including severe or uncontrolled cardiovascular disease (congestive heart failure New York Heart Association (NYHA) III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias 2. Pregnant or breast feeding 3. Concomitant or previous malignancy which is likely to interfere with protocol treatment 4. Inflammatory bowel disease 5. Previous pelvic radiotherapy 6. Bilateral hip replacements compromising accurate radiotherapy planning 7. Evidence of significant clinical disorder, or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial 8. Male and female patients (of childbearing age) not using adequate contraception 9. Significant decrease in GFR during previous chemotherapy treatments 10. Widespread carcinoma in situ (CIS), or CIS remote from the muscle invasive tumour 11. Simultaneous upper tract, urethral or prostatic transitional cell carcinoma 12. Untreated hydronephrosis 13. Participation in another trial within the previous 30 days [except for observational studies, e.g. Bladder Cancer Prognosis Programme (BCPP)]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility and toxicity; Timepoint(s): Phase I outcome | — |
Secondary
| Measure | Time frame |
|---|---|
| Cystoscopic local control at three months post-treatment; Timepoint(s): Primary outcome in Phase II | — |
Countries
England, United Kingdom
Outcome results
None listed