Topic: National Cancer Research Network
Conditions
Interventions
Each cycle of concurrent chemotherapy comprised 100 mg/m^2 gemcitabine given as an intravenous infusion over 30 minutes 2 - 4 hours before radiotherapy (RT) on day 1. Conformal radiotherapy using four
Sponsors
Christie Hospital NHS Foundation Trust (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed T2-3 N0M0 transitional cell carcinoma (TCC) of the bladder* 2. Life expectancy greater than 3 months 3. World Health Organization (WHO) performance status 0 ? 2 4. Patients opting for bladder preservation who are able and motivated to comply with follow up 5. Maximal achievable transurethral resection of bladder tumour (TURBT) 6. Serum creatinine less than 1.5 x upper limit of normal (ULN) 7. Haemoglobin (Hb) greater than 10 g/dl, platelets greater than 100,000/mm^3, white cell count (WCC) greater than 2000/mm^3 8. Aged greater than 18 years 9. Provided informed consent *Patients with TCC in whom biopsy fails to demonstrate histological evidence of muscle invasion but where magnetic resonance (MR) demonstrates unequivocal evidence of deep muscle invasion can be accepted for trial entry
Exclusion criteria
Exclusion criteria: 1. Residual tumour with any unidimensional measurement greater than or equal to 7 cm following TURBT 2. Poor bladder function: 2.1. Any WHO bladder symptom score equalling 3 or greater than or equal to two bladder symptom scores equalling 2 2.2. Documented bladder capacity less than or equal to 200 ml 3. Abnormal liver function tests (LFT) (bilirubin greater than 1.3 x ULN, alkaline phosphatase greater than 5 x ULN, transaminases greater than 5 x ULN) 4. Previous radiotherapy to pelvis 5. More than one instillation of intravesical cytotoxic chemotherapy or immunotherapy 6. Any previous systemic chemotherapy 7. Radiotherapy planning target volume (PTV) greater than 1000cm^3 8. Any prior malignancy (excluding basal cell carcinoma [BCC]) 9. Pre-existing medical conditions that preclude this treatment 10. Pregnant or breast-feeding 11. Not able to use appropriate and/or adequate contraception during and for 3 months after the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumour response, measured three months after completion of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Toxicity 2. Survival | — |
Countries
United Kingdom
Outcome results
None listed