Bladder Cancer
Conditions
Brief summary
This is a prospective, multi-centre randomised trial comparing between cTURBT plus 1-year BCG therapy, and ERBT plus 1-year BCG therapy, in patients with intermediate-risk or high-risk NMIBC.
Detailed description
All patients who are diagnosed to have bladder tumour(s) upon flexible cystoscopy will be screened for study eligibility. Imaging will be arranged to rule out any upper urinary tract malignancy. Patients are randomised to receive either transurethral ERBT or cTURBT with an allocation ratio of 1:1. A single dose of intravesical mitomycin C will be instilled according to the EAU guidelines, i.e. in all patients except those with a prior recurrence rate of more than one recurrence per year, or those with an EORTC recurrence score of ≥5. All patients will be followed up at our outpatient clinic and the pathology results will be reviewed. Routine second-look TURBT will be arranged within 2-6 weeks after the first operation should there be any indications as stated in the EAU guidelines. For patients in the intermediate or high-risk groups, 1-year of intravesical BCG therapy will be offered. Surveillance flexible cystoscopy will be performed at a 3-month interval until 2 years after the index surgery, and then every 6 months for another 3 years. Biopsy will be taken and TURBT will be offered if there is any suspicious tumour recurrence noted during surveillance cystoscopy.Primary outcome is recurrence-free survival at 2 years.
Interventions
PROCEDUREConventional Transurethral Resection of Bladder Tumour
Conventional TURBT is performed by resecting the bladder tumour in a piecemeal manner with a top-down approach. The bladder tumour specimen is fragmented during the procedure and whether a complete resection has been achieved is determined by the operating surgeon's judgment intra-operatively.
PROCEDURETransurethral En Bloc Resection of Bladder Tumour
This surgical technique resects the bladder tumour underneath the submucosal plane, and the bladder tumour can be removed in one piece.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients are randomised to receive either transurethral ERBT or cTURBT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or above * Fulfil any one of the following three criteria: 1. Recurrent bladder tumour 2. Multiple bladder tumours 3. Any bladder tumour size of \>1cm
Exclusion criteria
* EAU low-risk NIMBC as intravesical BCG therapy should not be offered (5) * EAU very high-risk NMIBC as upfront radical cystectomy should be offered (5) * Any prior use of intravesical BCG therapy * Presence or prior history of upper urinary tract malignancy * Presence of clinically significant cardiovascular disease (History of acute myocardial infarction, presence of uncontrolled angina within 3 months before screening, New York Heart Association Class III or IV congestive heart failure, presence of ventricular arrhythmias, or presence of second-degree or third-degree heart block) (16) * Presence of GOLD Stage III or IV chronic obstructive pulmonary disease * ECOG performance status ≥ 2 (Ambulatory and capable of all self-care but unable to carry our any work activities) (18) * History of bleeding disorder or use of anti-coagulants * Pregnancy * Presence of other active malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of recurrence-free survival | At Year 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of progression-free survival | At Year 2 | — |
| Cancer-specific survival | At Year 2 | — |
| Overall survival | At Year 2 | — |
| Adverse Events | On Day 30 after operation | By CTCAE V5.0 |
| Detrusor muscle sampling rate | On Day 30 after operation | — |
| Day of hospital stay | On Day 30 after operation | — |
| Total operation time | On Day 30 after operation | — |
Countries
Hong Kong
Contacts
CONTACTYuen Chun Jeremy TEOH, MD
CONTACTYuen Chun Jeremy TEOH
PRINCIPAL_INVESTIGATORYuen Chun Jeremy TEOH, MD
Chinese University of Hong Kong
Outcome results
None listed