Specialty: Cancer, Primary sub-specialty: Bladder
Conditions
Interventions
Participants will be randomised on a 1:1 basis to receive either RC or mBCG. A computer-generated adaptive minimisation algorithm that incorporates a random element will be used to ensure the treatmen
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria as of 23/03/2017: 1. Male or female aged = 18 years old. 2. Patients with a new diagnosis of high-risk (high grade or grade 3) non-muscle invasive urothelial carcinoma (staged as either pTa, pTis or pT1). Patients with previous low grade NMIBC are suitable. 3. The tumour is either solely urothelial cell carcinoma or has urothelial cell carcinoma as the majority histological component. 4. In addition to the HRNMIBC bladder tumour, there needs to be one or more risk factor from: 4.1. Presence of pTis in the bladder 4.2. Presence of pTis in the prostatic urethra 4.3. Lymphovascular invasion 4.4. Vascular invasion 4.5. Residual Grade 3/High grade UCC on re-resection (or initial TURBT if no re-resection) 4.6. Multifocal disease (>3 tumours at initial resection) 4.7. Young age ( 3cm (or >5g in histology specimen) 4.9. pT1 stage 5. Either re-resection of the bladder (following the initial diagnostic TURBT) within 3 months prior to randomisation confirming the absence of muscle invasion OR 5.1. The initial diagnostic TURBT biopsy contains muscle, AND 5.2. The radiological and pathological stage assessment are in agreement regarding stage and absence of muscle invasion, AND 5.3. A re-resection is not appropriate in the opinion of the treating clinician AND 5.4. The initial TURBT is within 3 months prior to randomisation 6. CT or cross sectional imaging of the abdomen and pelvis within the year prior to starting treatment. 7. Imaging of the lungs and thorax within 3 months prior to randomisation. 8. Suitable and fit for both mBCG and RC as determined by the treating clinician 9. Central MDT pathological review agrees diagnosis 10. If female, must be (as documented in patient notes): 10.1. Postmenopausal (no menses for 12 months without an alternative medical cause), or 10.2. Surgically sterile (hysterectomy, bilateral salpingectomy or bilateral oophorectomy), or 10.3. Using acceptable contraception2 (which must be continued for 7 days after the last dose of BCG or until RC is carried out). Women of child bearing potential must undergo a pregnancy test before randomisation. 10.4. Not breast feeding Original inclusion criteria: 1. Male or female aged = 18 years old 2. Patients with a new diagnosis of high-risk (high grade or grade 3) non-muscle invasive urothelial carcinoma (staged as either pTis, pTa or pT1). Patients with previous low grade NMIBC are suitable 3. The tumour is either solely urothelial cell carcinoma or has urothelial cell carcinoma as the majority histological component 4. In addition to the HRNMIBC bladder tumour, there needs to be one or more risk factor from: 4.1. Presence of pTis in the bladder 4.2. Presence of pTis in the prostatic urethra 4.3. Lymphovascular invasion 4.4. Vascular invasion 4.5. Residual Grade 3/High grade UCC on re-resection 4.6. Multifocal disease (>3 tumours at initial resection) 4.7. Young age ( 3cm (or >5g in histology specimen) 4.8. pT1 stage 5. Re-resection of the bladder (following the initial diagnostic TURBT) within 3 months prior to randomisation confirming the absence of muscle invasion 6. Suitable and fit for both mBCG and RC as determined by the treating clinician 7. Central MDT pathological review agrees diagnosis 8. If female, must be (as documented in patient notes): 8.1. Postmenopausal (no menses for 12 months without an alternative medical cause) 8.2. Surgically sterile (hysterectomy, bilateral sal
Exclusion criteria
Exclusion criteria: 1. Solely non-urothelial or variant urothelial pathology 2. Unable or not willing to give informed consent 3. Previous high risk (high grade or grade 3) NMI or invasive bladder cancer 4. Any previous treatment with intravesical BCG 5. Any other malignancy (excluding non-melanomatous skin cancer, low-risk prostate cancer and prior low risk bladder cancer)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Eligibility rate is reportedas the number of patients screened for entry to the study and considered eligible within the 18 month recruitment period 2. Recruitment rate is reported as the number of eligible patients randomised within the 18 month recruitment period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Uptake of allocated treatment is reported as the number of randomised participants starting their allocated treatment within the 21 month follow-up period 2. Treatment compliance is reported as the number of randomised participants complying with their allocated treatment regimen within the 21 month follow-up period 3. Withdrawal rate is reported as the number of randomised participants withdrawing from trial procedures within the 21 month follow-up period 4. Loss-to-follow-up rate is reported as the number of randomised participants for whom follow-up data cannot be collected within the 21 month follow-up period 5. Quality of life completion rate is reported as the number of randomised participants for whom quality of life data is available at baseline, 3, 6 and 12 months post-randomisation 6. Quality of life is measured by the EQ5D, EORTC QLQ-C30, EORTC QLQ-NMIBC24, QLQ-BLM-30 at baseline, 3, 6 and 12 months post-randomisation 7. Survival is measured at 12 months post-randomisation 8. Reasons participants / clinicians decline study entry is measured by a qualitative sub-study during the 18 month recruitment period | — |
Countries
England, United Kingdom
Contacts
Public ContactHeather Poad
Outcome results
None listed