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New radiation technique aims to slash gut damage in bladder cancer patients

NCT ID NCT05295992

Disease control Sponsor: Varian, a Siemens Healthineers Company 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 new type of daily radiation therapy for muscle-invasive bladder cancer that adapts to changes in the body each day. The goal is to see if this approach lowers the chance of diarrhea and other bowel problems compared to standard radiation. About 110 adults with bladder cancer that hasn't spread widely are taking part. The treatment is designed to be more precise, potentially causing fewer side effects.

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 110 people

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

Started

Mar 2022

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. Histologically proven bladder cancer 2. Urothelial carcinoma 3. Age ≥ 18 years 4. Stage T1b-T4AN0M0 5. TUR-B and PET-CT or CT of thorax/abdomen/pelvis within 8 weeks prior to inclusion 6. Suitable for radiotherapy 7. ECOG/WHO performance status 0-2 8. Written informed consent 9. For Cohort B, participant's must have normal organ and marrow function as defined below: * leukocytes ≥2,500/mcL * absolute neutrophil count ≥1,500/mcL * platelets ≥100,000/mcL * hemoglobin ≥9 g/dL * total bilirubin ≤ 1,5 ULN * AST(SGOT)/ALT(SGPT) ≤3 × ULN * alkaline phosphatase ≤2.5 × ULN * creatinine clearance \<25 ml/min We recommend avoiding cisplatin for participants with creatinine clearance \<50 ml/min. * INR and aPTT £1.5 ULN Exclusion Criteria: 1. Prior pelvic radiation therapy 2. Inability to comply with the protocol 3. Presence of a hip prothesis 4. Grade 2 or greater baseline diarrhea 5. Uncontrolled inflammatory bowel disease (ulcerative colitis or Crohn's disease)

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Conditions

The condition(s) this trial relates to.

infiltrating bladder urothelial carcinoma

As listed by the trial registrant

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

Muscle-invasive bladder carcinoma

Contacts and locations

Locations

  • Herlev and Gentofte Hospital

    Herlev, DK-2730, Denmark

More trials for these conditions

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