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Partial Cystectomy & Extended Pelvic Lymph Node Dissection for Bladder Cancer

This study is looking at whether removing only part of the bladder (partial cystectomy) along with nearby lymph nodes, combined with standard pre- and post-surgery treatments, can be an effective option for muscle-invasive bladder cancer. This approach aims to be less invasive than removing the entire bladder. You would receive standard chemotherapy before surgery, then undergo the partial cystectomy and lymph node removal, followed by standard post-surgery treatment. The study will measure how long participants live without their cancer returning (recurrence-free survival) for up to 24 months. It's for people aged 19 and older with specific types of bladder cancer that can be removed with a partial cystectomy. The study plans to enroll 40 participants, but its current status is unclear.

Study design
This is an interventional study with a planned enrollment of 40 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive standard pre-surgery chemotherapy for approximately 4 to 6 weeks, undergo a partial cystectomy with extended pelvic lymph node dissection, and then receive standard post-surgery systemic therapy.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for recurrence-free survival for up to 24 months from the date of their post-surgery baseline scan.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06290687

Partial Cystectomy & Extended Pelvic Lymph Node Dissection With SOC Perioperative Systemic Therapy

Recruiting
PHASE2Ages 19+InterventionalTreatment
Case Comprehensive Cancer Center
~40 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Neoadjuvant ChemotherapyPartial cystectomy with Extended pelvic lymph node dissectionAdjuvant systemic therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recurrence-Free Survival (RFS)
Measured over Up to 24 months from date of post-surgery baseline scan

Conditions

Malignant Neoplasm of Bladder
Muscle Invasive Bladder Carcinoma

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Bladder Carcinoma

NCT06290687

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Glickman Urological and Kidney Institute, Cleveland Clinic, Case Comprehensive Cancer Center

    Cleveland, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Nima Almassi, MD · PRINCIPAL_INVESTIGATOR · Cleveland Clinic, Case Comprehensive Cancer Center

Who to contact

Nima Almassi, MD
[email protected]
(216) 444-1825
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Recurrence-Free Survival (RFS)Up to 24 months from date of post-surgery baseline scan

    Recurrence-Free Survival (RFS) is defined as the time from post-surgery baseline scan (revealing no recurrent/metastatic disease) until the first occurrence of either local or distant recurrence as assessed by CT or MRI and/or biopsy. The primary outcome of distant RFS will be assessed via Kaplan-Meier analysis