Bladder cancer trial aims to save more of the bladder
NCT ID NCT06290687
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This study is for people with muscle-invasive bladder cancer that has not spread. It tests whether removing only the part of the bladder with cancer (partial cystectomy) plus nearby lymph nodes works as well as removing the whole bladder. Participants get standard chemotherapy before and after surgery. The goal is to control the cancer while preserving more bladder function and quality of life.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
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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19 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: * Subjects must have histologically confirmed urothelial carcinoma of the bladder, clinical stage T2-3N0M0. Micropapillary, glandular, squamous, and sarcomatoid histologic variants of urothelial carcinoma are allowed. * Subjects must have unifocal or limited multifocal disease amenable to complete surgical resection with partial cystectomy, as judged by the treating urologic oncologist. * Age \>18 years. Because of the rarity of this disease and limited data on treatment efficacy in subjects 18 years of age, children are excluded from this study. * Performance status - Karnofsky Performance Status ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status Grade 0 or 1. * Subjects must have normal organ and marrow function as defined below: * Total bilirubin within normal limits * AST (SGOT) ≤ 2.5 X institutional upper limit of normal * ALT (SGPT) ≤ 2.5 X institutional upper limit of normal * Bone marrow: * Absolute neutrophil count (ANC) ≥ 1,500/mm3 * Platelet count ≥ 80,000/mm3, Hemoglobin ≥ 9.0 g/dL * Subjects must have the ability to understand and the willingness to sign a written informed consent document. * Subjects must have tumor less than or equal to 5 cm in largest dimension as assessed radiographically. * Treatment naive for MIBC. Exclusion Criteria: * Presence of hydronephrosis. * Presence of multifocal disease that is not amenable to complete resection with partial cystectomy. * Presence of distant carcinoma in situ. * Presence of clinical N+ or M+ disease. * Presence of cT4+ disease. * Non-urothelial histology. * Concurrent upper tract (ureter or renal pelvis) or urethral urothelial carcinoma. * Subjects who are not surgical candidates due to competing medical comorbidities or who refuse surgical treatment. * Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
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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
1 site. 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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Glickman Urological and Kidney Institute, Cleveland Clinic, Case Comprehensive Cancer Center
RECRUITINGCleveland, Ohio, 44195, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New Drug-Radiation combo aims to spare bladders in cancer patients