Bladder Cancer Clinical Trial
Official title:
CALIBER - A Phase II Randomised Feasibility Study of Chemoresection and Surgical Management in Low Risk Non Muscle Invasive Bladder Cancer
Patients diagnosed with low risk non-muscle invasive bladder cancer (NMIBC) are at risk of
frequent low grade recurrence, which usually necessitates surgical intervention under general
anaesthetic. This multicentre study aims to establish the short term efficacy of
chemoresection using chemotherapy within the bladder for the treatment of NMIBC.
Should the levels of complete response following chemoresection meet predefined criteria, a
larger phase III trial would be developed to assess longer term disease related endpoints,
with the aim of standardising management of recurrent low risk NMIBC and potentially removing
the need for over a thousand patients each year to undergo surgery.
CALIBER is a two stage phase II, multicentre, randomised controlled trial (RCT). A control
group has been included to provide prospective data about surgical management and outcomes
and assess feasibility of recruitment to a randomised study.
Stage 1: 80 patients will be recruited with treatment allocated 2:1 by randomisation between
chemoresection and surgical management.
Stage 2: If the stop/go activity criteria at the end of stage 1 indicate that recruitment
should continue, 9 additional participants will be recruited, all of whom will receive
chemoresection.
Patients assigned to the chemoresection group will receive 4 once weekly intravesical
instillations of 40mg Mitomycin C (MMC) as outpatients. This treatment will be delivered via
catheter under local anaesthetic.
Patients assigned to the surgical management group will receive the standard surgical
management in use at their hospital for treatment of recurrence which may include a single
post-operative installation of 40mg MMC within 24 hours.
All participants will be followed up at 3 weeks from the start of treatment (ie at time of
final MMC instillation for chemoresection group) and each will receive a cystoscopy three
months from the end of treatment to assess response, in accordance with European Association
of Urology (EAU) guidelines.
Subsequent cystoscopic follow up will take place 12 months after treatment if recurrence-free
at 3 months and then annually.
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