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New radiation technique aims to cut bowel problems in bladder cancer treatment

NCT ID NCT07043543

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a newer, more precise radiation method (adaptive radiotherapy) for people with muscle-invasive bladder cancer who cannot have surgery or choose not to. The goal is to see if this technique reduces bowel side effects like diarrhea compared to standard radiation. About 120 adults with certain types of bladder cancer will take part.

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

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Sep 2033

An estimate. End dates often move.

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: * Histologically proven muscle-infiltrating bladder cancer (de novo MIBC or after a history of non-muscle-invasive bladder cancer) or patients with initial high-grade T1 tumor showing Ta or T1 recurrence, or those with high-grade T1 after a course of intravesical biological therapy or chemotherapy; * Age ≥ 18 years; * Urothelial carcinoma (transitional cell carcinoma of the bladder, micropapillary, microcystic with trophoblastic differenciation) and squamous cell histological types are allowed; * Stage T1-T4aN0M0 * TransUrethral Resection of Bladder Tumor (TURBT) and Position Emission Tomography- scanner and X-ray Computed Tomography (PET-CT) or Computed Tomography scan of thorax/abdomen/pelvis (without carcinological anomaly) within 8 weeks prior to the start of radiation therapy (if TURBT was performed more than 6 weeks before the inclusion visit, a new TURBT or, at least, a cystoscopy showing no progression, no residual tumour or regrowth must be done); * Suitable for radiotherapy; * Eastern Cooperative Oncology Group/World Human Organisation (ECOG/WHO) performance status from 0 to 2 * Negative pregnancy test (blood or urine), for women of childbearing age only; * If the patient is sexually active, he/she must agree to use contraception deemed adequate and appropriate by the investigator throughout the period of study drug administration and 6 months after the end of treatment for both men and women. * Affiliation to the French Social Security System; * Dated, written and signed Informed consent Exclusion Criteria: * Prior pelvic radiation therapy; * Patients with previous or concomitant other malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for at least five years; * Presence of endopenic stent; * Inability to comply with the protocol; * Grade 1 or greater baseline diarrhea; * Uncontrolled inflammatory bowel disease (ulcerative colitis or Crohn's disease); * Uncontrolled immune or cardiac or pulmonary disease; * Patients whose regular follow-up is impossible for psychological, family, social or geographical reasons; * Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study; * Pregnant or breast-feeding subjects

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre Eugène Marquis

    Rennes, Ille et Vilaine, 35000, France

  • Centre Georges François Leclerc

    Dijon, Côte d'or, 21079, France

  • Centre Henri Becquerel

    Rouen, Seine Maritime, 76038, France

  • Centre Oscar Lambret

    Lille, Nord, 59000, France

  • Centre de radiothérapie Bayard

    Villeurbanne, Rhone, 69100, France

  • Centre de radiothérapie Saint-Louis

    Toulon, Var, 83100, France

  • Hôpital Tenon

    Paris, Île-de-France Region, 75020, France

  • Institut Curie

    Saint-Cloud, Île-de-France Region, 92210, France

  • Institut Sainte Catherine

    Avignon, Var, 84000, France

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, Loire Atlantique, 44800, France

  • Institut du Cancer de Montpellier

    Montpellier, Herault, 34298, France

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