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

NCT ID: NCT06290687

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-18
• Study Completion Date: 2027-01-29

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.

Detailed Description

Radical cystectomy (surgical removal of the bladder) with pelvic lymph node dissection and urinary diversion, with neoadjuvant chemotherapy in eligible participants, is the standard of care in participants with muscle-invasive bladder cancer (MIBC). While this has demonstrated efficacy in the treatment of MIBC, it has risk of perioperative morbidity and impacts quality of life. Partial cystectomy (surgical removal of a portion of the bladder) is one option for bladder-sparing treatment of select bladder cancer participants and is included in the National Comprehensive Cancer Network bladder cancer treatment guidelines. This treatment has the advantage of less invasive treatment with a lower risk of surgical complication and better health-related quality of life (HRQOL) while providing pathologic staging, however there are limited data on outcomes with this treatment, especially patient-reported HRQOL outcomes. Additionally, much of the existing literature on efficacy of this treatment predates the use of advanced imaging in preoperative staging and advances in surgical technique including use of minimally-invasive surgical approaches and enhanced-recovery post-operative care paths. Given these limitations in the existing literature, the aim of this clinical trial is to examine the safety and efficacy and HRQOL outcomes of partial cystectomy with extended pelvic lymph node dissection, with standard of care perioperative systemic therapy in eligible participants.

Conditions

Malignant Neoplasm of Bladder; Muscle Invasive Bladder Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Neoadjuvant Chemotherapy

Intervention Type: DRUG

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

Intervention Type: PROCEDURE

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

Intervention Type: DRUG

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.

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

Group Type: EXPERIMENTAL

Partial cystectomy with Extended pelvic lymph node dissection

Intervention Type: PROCEDURE

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

Intervention Type: DRUG

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.

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)

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nima Almassi, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic, Case Comprehensive Cancer Center

Locations

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

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nima Almassi, MD

Role: CONTACT

almassn2@ccf.org

(216) 444-1825

Facility Contacts

Nima Almassi, MD

Role: primary

almassn2@ccf.org

216-444-1825

Other Identifiers

CASE5824

Identifier Type: -

Identifier Source: org_study_id