Recruiting
Phase 2

Partial Cystectomy

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT06290687

Conditions

Malignant Neoplasm of Bladder

Muscle Invasive Bladder Carcinoma

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Neoadjuvant Chemotherapy

Partial cystectomy with Extended pelvic lymph node dissection

Adjuvant systemic therapy

Study Details

Brief summary:

The goal of this clinical trial is to determine if a partial cystectomy with extended pelvic lymph node removal will be effective at treating Muscle-Invasive Bladder Cancer instead of a complete cystectomy with extended pelvic lymph node removal. This clinical trial aims to determine the safety and oncologic efficacy of the intervention, and to examine patient-reported quality of life outcomes in participants. Participants will receive the standard pre-surgery treatment for approximately 4 to 6 weeks. After the pre-surgery treatment is completed, participants will undergo a partial cystectomy with extended pelvic lymph node dissection. After surgery, participants will receive adjuvant systemic therapy.

Conditions

Malignant Neoplasm of Bladder

Muscle Invasive Bladder Carcinoma

Study ID

NCT06290687

Start date

Sep, 2026

Status verified date

Aug, 2026

Completion date

Dec 29, 2027

Anticipated

Primary completion date

Dec 29, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cisplatin Eligible Participants

Participants who are deemed eligible for cisplatin-based NAC will undergo:

  • Standard of care neoadjuvant systemic therapy (currently cisplatin-based chemotherapy in cisplatin-eligible participants)
  • Partial cystectomy with extended pelvic lymph node dissection
  • Standard of care adjuvant systemic therapy in eligible patients

experimental: Cisplatin Ineligible Participants

Participants who are deemed ineligible for cisplatin-based NAC will undergo:

  • Partial cystectomy with extended pelvic lymph node dissection
  • Standard of care adjuvant systemic therapy in eligible participants

Interventions

Neoadjuvant Chemotherapy

Standard of care neoadjuvant systemic therapy is currently cisplatin-based chemotherapy in cisplatin-eligible participants. Participants will start treatment within 60 days of Transurethral Resection of Bladder Tumor. Regimens may include:

  • Cisplatin - Gemcitabine (Gem/Cis)
  • Dose Dense Methotrexate - Vinblastine - Adriamycin - Cisplatin (MVAC)

Partial cystectomy with Extended pelvic lymph node dissection

Partial cystectomy will then be performed using the surgical technique at the discretion of the treating Urologic Oncologist. Extended pelvic lymphadenectomy will then be performed at the discretion of the treating Urologic Oncologist. Surgery will be performed within 60 days of Transurethral Resection of Bladder Tumor for Cisplatin-ineligible participants. Surgery will be performed within 60 days of completing neoadjuvant chemotherapy for Cisplatin-eligible participants.

Adjuvant systemic therapy

Standard of care adjuvant systemic therapy in eligible participants. The choice of adjuvant systemic therapy will be left to the discretion of the treating Medical Oncologist but must fall within the SOC as outlined in NCCN guidelines.

Primary outcome measure

  • Recurrence-Free Survival (RFS) [ Time Frame: Up to 24 months from date of post-surgery baseline scan ]

Central Contacts and Locations

Central contacts

Nima Almassi, MD

(216) 444-1825almassn2@ccf.org

Locations

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

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Nima Almassi, MD

216-444-1825almassn2@ccf.org

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • Partial cystectomy
  • Pelvic Lymph Node Dissection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-08-06.