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Timing chemotherapy around bladder surgery may cut recurrence

NCT ID NCT02075060

Disease control Sponsor: Poitiers University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests whether giving the chemotherapy drug mitomycin C into the bladder just before tumor removal works better than giving it right after. The goal is to reduce the chance that non-muscle-invasive bladder tumors come back. Adults with one or two bladder tumors will be randomly assigned to one of the two timings. Researchers will track how long it takes for a recurrence to appear on follow-up cystoscopy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mitomycin C, a chemotherapy drug, given as a single instillation into the bladder either just before or right after endoscopic tumor removal.
What this could lead to
If giving the drug before surgery works better, it could lower the chance of bladder tumors coming back after removal.
What could go wrong
This is a small, early-stage trial with 60 participants, so results may not apply broadly. The drug can cause bladder irritation or allergic reactions.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Feb 2014

Finished

Jan 2018

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: * Age \> 18 years, * Primary or recurrent bladder tumor with endoscopic papillary aspect, * One or two bladder tumors, * Cytology before RTUV showing no high-grade cells, * Patients without tutorship or subordination (ou curatorship), * Patients under the general social security system or qualifying through a third party, * Informed consent signed by the patient after clear and fair information. Exclusion Criteria: * Age \< 18 years, * Allergy to mitomycin C, * Traumatic stenting, * Upper tract urothelial cancer, * Urethral invasion, * History of muscle invasive bladder cancer, * Extensive tumor (3 cm or more), * Any contraindication to RTUV, * Simultaneous participation in another clinical research study, * Patients not insured by the social security or not qualifying through a third party, * Patients with enhanced protection, namely pregnant or lactating women, persons deprived of their liberty by a judicial or administrative decision, people staying in a health or social institution, adults under legal protection, and finally patients in emergency situations, * Pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study (i.e. hormonal / mechanical contraceptive : oral, injectable, transdermal, implantable, intrauterine or surgical device: tubal ligation, hysterectomy, total oophorectomy).

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Conditions

The condition(s) this trial relates to.

non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms superficial urinary bladder carcinoma

As listed by the trial registrant

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

Non muscle invasive bladder cancer

Contacts and locations

Locations

  • Bicêtre Hospital

    Le Kremlin-Bicêtre, 94270, France

  • Poitiers University Hospital

    Poitiers, 86100, France

  • Rouen University Hospital

    Rouen, 76000, France

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