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Bladder cancer: can faster chemo before surgery boost cure rates?

NCT ID NCT07184021

Disease control Sponsor: Assiut University 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 2 trial tests a dose-dense (faster) schedule of two chemotherapy drugs, gemcitabine and cisplatin, given before surgery for muscle-invasive bladder cancer. The goal is to see if this approach can completely eliminate the tumor in the bladder and lymph nodes. Thirty eligible patients will receive four cycles of the chemo regimen before undergoing bladder removal surgery, and researchers will measure how many achieve a complete pathological response.

What this could mean

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

Active substance
gemcitabine and cisplatin
What this could lead to
If successful, this could lead to a more effective chemotherapy regimen before bladder cancer surgery, potentially improving survival and reducing recurrence.
What could go wrong
This is a small, early-phase trial with only 30 participants. The intensive chemo schedule may cause side effects, and results may not apply to all patients.

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 30 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Sep 2027

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 confirmed urothelial carcinoma of the bladder, clinical stage T2-T4a, N0-N1, M0. * Eligible and fit for cisplatin-based chemotherapy (e.g., creatinine clearance ≥ 60 mL/min). * Candidate for radical cystectomy after neoadjuvant treatment. * ECOG performance status 0-1. * Adequate bone marrow, liver, and renal function as per institutional standards. Exclusion Criteria: Histology predominantly other than urothelial carcinoma (e.g., small cell, squamous cell ≥50%). * Clinical or radiological evidence of distant metastases (M1). * Prior systemic chemotherapy or radiotherapy for bladder cancer. * Significant renal impairm ent (creatinine clearance \< 60 mL/min). * ECOG performance status ≥ 2. * Significant comorbidities contraindicating chemotherapy (e.g., uncontrolled cardiac disease, severe infection).

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Conditions

The condition(s) this trial relates to.

infiltrating bladder urothelial carcinoma urinary bladder cancer Urinary Bladder Neoplasms

As listed by the trial registrant

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

Urinary bladder cancer

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

  • Assiut university Hospital-Departement of clinical oncology.

    Asyut, Egypt

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