Chemoablation or bladder resection with adjuvant chemotherapy in recurrent non-muscle invasive bladder cancer

Conditions

Recurrent non-muscle invasive bladder cancer

Brief summary

• Two-year RFS. This is defined as event of first recurrence following treatment but not including the recurrence diagnosed at the time of inclusion or persisting tumour following chemoablation.

Detailed description

• Five-year RFS, • Number of patients in need of a TURBT or tumour fulguration in the outpatient clinic in the first two years following randomisation, • Number of tumours at first recurrence based on the following intervals: 1, 2-7, > 8, • Number of TURBTs per patient in the first two and five years of follow-up based on the following intervals: 1, 2-5, 5-10 and multiple, • Five-year progression free survival (progression defined as progression to T1-tumour, T2+-tumour, or cystectomy irrespectively of indication), • Five-year overall survival, • Number of patients completing assigned intervention, • Serious adverse events related to MMC treatment during neoadjuvant or adjuvant therapy

Related papers

No related papers found yet.

Interventions

DRUGMitomycin medac 40 mg powder and solvent for intravesical solution

DRUGBCG medac

DRUGpowder and solvent for intravesical suspension

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
• Two-year RFS. This is defined as event of first recurrence following treatment but not including the recurrence diagnosed at the time of inclusion or persisting tumour following chemoablation.	—

Secondary

Measure	Time frame
• Five-year RFS, • Number of patients in need of a TURBT or tumour fulguration in the outpatient clinic in the first two years following randomisation, • Number of tumours at first recurrence based on the following intervals: 1, 2-7, > 8, • Number of TURBTs per patient in the first two and five years of follow-up based on the following intervals: 1, 2-5, 5-10 and multiple, • Five-year progression free survival (progression defined as progression to T1-tumour, T2+-tumour, or cystectomy irrespectively of indication), • Five-year overall survival, • Number of patients completing assigned intervention, • Serious adverse events related to MMC treatment during neoadjuvant or adjuvant therapy	—

Measure

Time frame

• Five-year RFS, • Number of patients in need of a TURBT or tumour fulguration in the outpatient clinic in the first two years following randomisation, • Number of tumours at first recurrence based on the following intervals: 1, 2-7, > 8, • Number of TURBTs per patient in the first two and five years of follow-up based on the following intervals: 1, 2-5, 5-10 and multiple, • Five-year progression free survival (progression defined as progression to T1-tumour, T2+-tumour, or cystectomy irrespectively of indication), • Five-year overall survival, • Number of patients completing assigned intervention, • Serious adverse events related to MMC treatment during neoadjuvant or adjuvant therapy

—

Countries

Denmark, Iceland, Norway, Sweden

Outcome results

None listed