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NCT Number: NCT06781879

Chemoablation Or Bladder Resection With Adjuvant Chemotherapy in Recurrent Non-Muscle Invasive Bladder Cancer

The investigartors will conduct a randomized, multinational study with the aim to assess if the efficacy of a dose dense chemoablation with Mitomycin C (MMC) with adjuvant BCG in non-responding patients is superior regarding long term effect compared to standard treatment with trans urethral resection of bladder tumors (TURBT) and adjuvant intravesical instillation therapy in patients with recurrent Ta LG tumors.

The study is a natural follow-up study following the pivotal NICSA trial supported by the Danish Cancer Society that has lead to the initial change in the European guidelines. In order to not only be comparable to current standard, but also to improve clinical outcome and furthermore confirm the previous findings, the investigators here suggest to implement at patient tailored approach through a new multicenter RCT.

The investigators hypothesize that chemoablation with MMC in patients with recurrent Ta LG tumors 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 favorable long term recurrence free survival (RFS) rate compared to the current standard regimen where all patients are treated with TURBT and adjuvant instillation therapy.

The incidence of bladder cancer in Denmark is almost 2,000 per year. Of these, 75% have non-muscle invasive bladder cancer (NMIBC). The yearly recurrence rate of NMIBC is approximately 35% and the disease is therefore one of the most costly cancers to manage on a per patient basis, due to the cost of operative procedures, follow-up cystoscopies and instillation therapies

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Key information

Conditions

Non-Muscle Invasive Bladder Cancer Carcinoma Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aalborg University Hospital, Aalborg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Tumour recurrence after previous urothelial tumour of Ta low-grade
  • Tumours smaller than 2 cm in diameter
  • Negative urine cytology (optional)
  • ≥18 years of age
  • Ability to understand and comprehend the provided written and oral information
  • Has provided written consent

Exclusion criteria

  • Known history of invasive tumour of the bladder (T1+)
  • Known history of CIS of the bladder
  • Previous MMC or BCG-treatment except for single instillations following previous TURBTs
  • Known allergy or intolerance to MMC
  • Solid tumour with suspicions of invasion
  • Tumour in the bladder neck or urethra
  • Suspicion of CIS (positive cytology with high-grade neoplastic cells combined with suspicious flat lesions seen at cystoscopy)
  • Small bladder volume (less than 100 ml) or incontinence
  • Prior radiation therapy to the pelvic area, as radiation affects the bladder function and instillation therapy is a suboptimal treatment for this patient group
  • Acute cystitis
  • Pregnancy or breast-feeding
  • Averse to using secure contraception with regard to men with partners and premenopausal women

Treatment and study plan

mitomycin C

Drug

Chemoablation

Primary outcomes

  1. Two-year Recurrence Free Survival

    Time frame: 2 years

    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 outcomes

  1. Five-year RFS

    Time frame: 5 years

    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.

  2. Number of patients in need of a TURBT or tumour fulguration in the outpatient clinic in the first two years following randomisation

    Time frame: 2 years

    need for TURBT/fulgaration

  3. Number of tumours at first recurrence based on the following intervals: 1, 2-7, > 8

    Time frame: 5 years

    tumour number

  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

    Time frame: 5 years

    number of TURBTs

  5. Five-year progression free survival

    Time frame: 5 years

    (progression defined as progression to T1-tumour, T2+-tumour, or cystectomy irrespectively of indication)

  6. Five-year overall survival

    Time frame: 5 years

    survival

  7. Number of patients completing assigned intervention

    Time frame: 2 years

    completing assigned intervention

  8. Serious adverse events related to MMC treatment during neoadjuvant or adjuvant therapy

    Time frame: 2 years

    SAE's

Study contacts

Contact information is provided by the study sponsor or research team.

Pernille Kingo, PhD, Dr

CONTACT

[email protected]

0045 78 45 00 00

Vibeke Morrison, Rn, Msc Nurs

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Jakob Kristian Jakobsen

Other

Collaborators

  • Danish Cancer Society
  • medac GmbH

Registry information

Acronym: COBRA-NMIBC

Important dates

Study start
2025
Primary completion
2029
Study completion
2032
First posted
Jan 17, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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