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Can Pre-Surgery chemotherapy outsmart aggressive bladder cancer?

NCT ID NCT07762586

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether giving chemotherapy before surgery to remove the bladder improves outcomes for people with a specific type of muscle-invasive bladder cancer called luminal subtype. Half the participants will receive standard neoadjuvant chemotherapy followed by cystectomy, while the other half will have surgery right away. The study will compare how often the cancer is found to have spread at the time of surgery, as well as changes in quality of life.

What this could mean

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

Active substance
Neoadjuvant chemotherapy (standard of care) followed by radical cystectomy, compared with upfront radical cystectomy alone
What this could lead to
If effective, this approach could reduce the chance of cancer spreading and improve long-term outcomes for people with this bladder cancer subtype.
What could go wrong
This is a small, early-phase trial, so results may not be definitive. Chemotherapy can cause side effects, and not all patients may benefit.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

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

Started

Jul 2026

Expected to finish

Jul 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 to 90 years

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: * ▪ Inclusion Criteria * Willing and able to provide informed consent * Age ≥18 years old * Eligible to receive standard of care systemic neoadjuvant therapy * Eastern Cooperative Group (ECOG) performance status of 0-1 * Documented histologically confirmed urothelial muscle-invasive bladder cancer * cT2N0M0 bladder cancer based on pre-TURBT bimanual exam and cross-sectional imaging performed within 8 weeks of surgery or initiation of NAT. * Willing to undergo RC with urinary diversion * No signs of extravesical disease on pre-TURBT conventional imaging * Variant histology is allowed so long as the tumor is predominantly urothelial carcinoma. * No presence of LVI on TURBT * Decipher Bladder GSC test result * Ineligible for or refusing TMT * No cN+ * The population is adult men or women of any ethnicity diagnosed with muscle-invasive bladder cancer. Exclusion Criteria: * Patients under 18 years old. Considering the minimal incidence of bladder cancer among the pediatric population, children are not eligible for this study. * Not willing or unable to give informed consent. * Clinical or pathological evidence of metastatic disease, including, non-regional lymph nodes, visceral lesions, and bone lesions. * Significant hepatic impairment (Serum bilirubin \> 1.5x upper limit of normal). * Significant renal impairment (creatinine clearance \<30 ml/min). * Predominant variant histology (i.e. nested, micropapillary, sarcomatoid, plasmacytoid, small cell)6 * cT3 bladder cancer on pre-TURBT bimanual exam or with hydronephrosis on cross-sectional imaging performed within 8 weeks of surgery or initiation of NAT * TURBT specimen with lymphovascular invasion (LVI) cT4 or unresectable bladder cancer * Concurrent diagnoses of other, non-urothelial, malignancies or prior malignancy diagnoses within the past three years. Exceptions, determined at the discretion of the principal investigator, include squamous cell carcinoma, basal cell carcinoma, or other low-grade cancer not expected to progress or require surgical/systemic therapy. * Prior history of systemic treatment for non-urothelial malignancies in the past three years, including chemotherapy and immunotherapy. * Prior diagnosis or evidence of psychiatric or medical conditions that may prevent patients from giving full and properly informed consent. * Any medical, familial, psychiatric, or geographic considerations that may prevent patients from study participation or follow-up required by the study protocol * Patients (cN+) are excluded from participation and are not eligible for enrollment. * Prisoners, Individuals without Decisional Capacity, and Pregnant Women will be excluded.

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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

    1 site. 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

  • Rutgers Cancer Institute

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

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