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NCT07724886

Overview

NCT ID: NCT07724886
Lead Sponsor: Chinese University of Hong KongOTHER
Official Title: A Randomised Trial Investigating the Role of Transurethral En Bloc Resection of Bladder Tumour Plus Intravesical Bacillus Calmette-Guerin Therapy, in Patients With Intermediate-Risk or High-Risk Non-Muscle-Invasive Bladder Cancer
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.
Conditions: Bladder Cancer
Interventions: Conventional Transurethral Resection of Bladder Tumour

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Age 18 years or above

Fulfil any one of the following three criteria:

Recurrent bladder tumour

Multiple bladder tumours

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

Central Contacts: Yuen Chun Jeremy TEOH, MDContact
jeremyteoh@surgery.cuhk.edu.hk35053933