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New chemo approach may cut bladder cancer return rates

NCT ID NCT03348969

Disease control Sponsor: Jørgen Bjerggaard Jensen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether giving a short, intensive course of the chemotherapy drug Mitomycin C before surgery (chemoresection) could lower the chance of bladder cancer coming back, compared to the usual approach of surgery followed by regular chemotherapy instillations into the bladder. The trial involved 120 adults with recurrent non-muscle invasive bladder cancer. The main goal was to see how many people needed additional surgery or tumor removal within two years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

120 people

The number who actually took part.

Started

Nov 2017

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Known history of urothelial non-invasive Ta-tumour low-grade or high-grade. * ≥18 years old * Mentally healthy individual * The ability to understand Danish orally and in writing Exclusion Criteria: * Known history of invasive tumour of the bladder (T1+) * Known history of CIS of the bladder * Previous BCG-treatment within the last 24 months * Previous Mitomycin C-treatment (except single-shot postoperative instillation) * Known allergy or intolerance to Mitomycin C * Solid tumour with suspicions of invasion * Single tumour of more than 2 cm in diameter * Suspicion of CIS (positive cytology with high-grade neoplastic cells combined with suspicious cystoscopy for flat lesions). * Small bladder volume (less than 100 ml) or incontinence * Acute cystitis * Pregnancy or breast-feeding * Not willing to use secure contraception with regard to men with partners and premenopausal women

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Conditions

The condition(s) this trial relates to.

non-invasive bladder urothelial carcinoma urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bladder cancer

Contacts and locations

Locations

  • Aarhus University Hospital

    Aarhus, 8200, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.