New radiation technique aims to cut bowel problems in bladder cancer treatment
NCT ID NCT07043543
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2033
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
11 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Centre Eugène Marquis
Rennes, Ille et Vilaine, 35000, France
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Centre Georges François Leclerc
Dijon, Côte d'or, 21079, France
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Centre Henri Becquerel
Rouen, Seine Maritime, 76038, France
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Centre Oscar Lambret
Lille, Nord, 59000, France
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Centre de radiothérapie Bayard
Villeurbanne, Rhone, 69100, France
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Centre de radiothérapie Saint-Louis
Toulon, Var, 83100, France
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Hôpital Tenon
Paris, Île-de-France Region, 75020, France
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Institut Curie
Saint-Cloud, Île-de-France Region, 92210, France
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Institut Sainte Catherine
Avignon, Var, 84000, France
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Institut de Cancérologie de l'Ouest
Saint-Herblain, Loire Atlantique, 44800, France
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Institut du Cancer de Montpellier
Montpellier, Herault, 34298, France
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Other studies related to the condition(s) this trial covers.
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- Can a radioactive antibody light up hidden tumors on PET scans?
- Can a radioactive drug seek out and attack solid tumors?