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Could skipping chemo speed up bladder cancer surgery without harm?

NCT ID NCT05776758

Disease control Sponsor: Regina Elena Cancer Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This phase 3 trial asks whether removing the bladder right away is as effective as giving chemotherapy first, for patients with muscle-invasive bladder cancer who have no visible tumor left after a thorough biopsy. About 236 adults will be randomly assigned to either surgery alone or chemo plus surgery. The goal is to see if skipping chemo avoids unnecessary side effects and delays without reducing survival.

What this could mean

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

Active substance
cisplatin-based neoadjuvant chemotherapy
What this could lead to
If skipping chemo proves as effective, patients could avoid unnecessary side effects and get surgery sooner.
What could go wrong
The trial is still recruiting and results are not yet available. Skipping chemo might slightly increase the risk of cancer returning, and the study only applies to a specific patient group.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 236 people

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

Started

Aug 2026

Expected to finish

Jan 2029

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: * diagnostic TURBt with cT2-4, cN0, cM0; * non-radiologic or endoscopic residual tumor after a maximal TURBt (cT0); * patients eligible to curative intent, candidate to surgical treatment and/or NAC (all patients must meet all the criteria required to be able to undergo RC and/or NAC); * ≥ 18 yrs old; * compliants patients able to follow the study protocol and fill in EORTC quality of life questionnaires; * patients able to provide a written informed consent for the trial Exclusion criteria: * anaesthesiologic contraindications to surgery; * palliative intent; * patients ineligible for cisplatin-combination chemotherapy

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Conditions

The condition(s) this trial relates to.

chemotherapy-induced toxicity infiltrating bladder urothelial carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

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

Chemotherapy effect Muscle-invasive bladder carcinoma Surgery

Contacts and locations

Locations

  • Riccardo Mastroianni

    Rome, 00144, Italy

More trials for these conditions

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