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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Aarhus University

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

26 May 2025 → ongoing

Decision date (initial)

2024-12-03

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

medac GmbH

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

The aim of the study is to assess if the efficacy of a dose dense chemoablation with MMC is superior regarding long term effect compared to standard treatment with TURBT and adjuvant intravesical instillation therapy in patients with recurrent Ta LG tumours.

Secondary objectives 1

1. We hypothesize that chemoablation with MMC in patients with recurrent Ta LG tumours will result in a permanent low recurrence rate in patients with complete response whereas patients without complete response can be selected for adjuvant BCG which theoretically is more efficient in this select patient group. This will potentially result in a more favourable long term recurrence free survival (RFS) compared to the current standard regimen where all patients are treated with TURBT and adjuvant instillation therapy. We also hypothesize that a reduction in the number of TURBTs over time will be seen in the chemoresected group based on avoidance of TURBTs in patients with complete response and less recurrences.

Conditions and MedDRA coding

Recurrent non-muscle invasive bladder cancer

Study design 1 period

Regulatory references

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. • Tumour recurrence after previous urothelial tumour of Ta low-grade (previous Ta high-grade is allowed, but latest histology must be Ta low-grade)
2. • Largest tumour smaller than 2 cm in diameter
3. • Negative urine cytology (optional)
4. • ≥18 years of age
5. • Ability to understand and comprehend the provided written and oral information
6. • The patient's mental well-being is assured

Exclusion criteria 16

1. • Known history of invasive tumour of the bladder (T1+)
2. • Non-treated Aacute cystitis at enrolment
3. • Pregnancy or breast-feeding
4. • Averse to using secure contraception with regard to men with partners and premenopausal women
5. • Known history of CIS of the bladder
6. • Previous MMC or BCG-treatment within the last 3 years except for single instillations following previous TURBT or nephoureterectomy
7. • Known allergy or intolerance to MMC or BCG
8. • Solid tumour with suspicions of invasion
9. • Tumour in the urethra
10. • Suspicion of CIS (positive cytology with high-grade neoplastic cells combined with suspicious flat lesions seen at cystoscopy)
11. • Small bladder volume (less than 100 ml) or profuse incontinence >50 grams a day
12. • Prior radiation therapy to the pelvic area
13. • Tumour in the bladder neck if it is visually evaluated as placed in an area being non-exposed to MMC during chemoablation
14. • Urothelial carcinoma outside of the urinary bladder or a histological variant of urothelial carcinoma. Ta/any T1 or CIS of the upper urinary tract is allowed if treated with complete nephroureterectomy more than 24 months prior to enrolment and without any evidence of recurrence
15. • Permanent indwelling catheter if not using a valve
16. • Known immunosupressed or known autoimmune disease

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. • 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 endpoints 8

1. • Five-year RFS
2. • Number of patients in need of a TURBT or tumour fulguration in the outpatient clinic in the first two years following randomisation
3. • Number of tumours at first recurrence based on the following intervals: 1, 2-7, > 8
4. • 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
5. • Five-year progression free survival (progression defined as progression to T1-tumour, T2+-tumour, or cystectomy irrespectively of indication)
6. • Five-year overall survival
7. • Number of patients completing assigned intervention
8. • Serious adverse events related to MMC treatment during neoadjuvant or adjuvant therapy

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Aarhus University

Sponsor organisation

Aarhus University

Address

Palle Juul-Jensens Boulevard 82

City

Aarhus N

Postcode

8200

Country

Denmark

Scientific contact point

Organisation

Aarhus University

Contact name

Charlotte Graugaard-Jensen

Public contact point

Organisation

Aarhus University

Contact name

Charlotte Graugaard-Jensen

Third parties 1

Locations

4 EU/EEA countries · 9 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 18 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications