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Role of ERBT Plus Intravesical BCG in Intermediate-Risk or High-Risk NMBC

RecruitingNAAges 18 Years - anyAllChinese University of Hong Kong
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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
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What it tests

  • Conventional Transurethral Resection of Bladder Tumour
  • Transurethral En Bloc Resection of Bladder Tumour
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Where

2 sites
Prince of Wales Hospital
Hong Kong, Hong Kong
North District Hospital
Sheung Shui, Hong Kong
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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