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

NCT06290687 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CASE5824
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Partial cystectomy; Pelvic Lymph Node Dissection

Outcome Measures

Primary Outcomes (1)

• Recurrence-Free Survival (RFS)

  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

  Up to 24 months from date of post-surgery baseline scan

Secondary Outcomes (6)

• Presence of Post-operative Complications

  At 90 days after surgery

• Median Bladder RFS

  Up to 24 months from date of post-surgery baseline scan

• Median Muscle-Invasive Bladder RFS

  Up to 24 months from date of post-surgery baseline scan

• Median Bladder-Intact Survival

  Up to 24 months from date of post-surgery baseline scan

• Median Cancer-Specific Survival

  Up to 24 months from date of post-surgery baseline scan

Study Arms (2)

Cisplatin Eligible Participants

EXPERIMENTAL

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

Drug: Neoadjuvant Chemotherapy; Procedure: Partial cystectomy with Extended pelvic lymph node dissection; Drug: Adjuvant systemic therapy

Cisplatin Ineligible Participants

EXPERIMENTAL

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

Procedure: Partial cystectomy with Extended pelvic lymph node dissection; Drug: Adjuvant systemic therapy

Interventions

Neoadjuvant Chemotherapy 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)

Cisplatin Eligible Participants

Partial cystectomy with Extended pelvic lymph node dissection 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.

Cisplatin Eligible Participants; Cisplatin Ineligible Participants

Adjuvant systemic therapy 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 Eligible Participants; Cisplatin Ineligible Participants

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

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

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Neoadjuvant Therapy; Cystectomy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Nima Almassi, MD

  Cleveland Clinic, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nima Almassi, MD

CONTACT

(216) 444-1825; almassn2@ccf.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-center, prospective, phase II trial.

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: February 18, 2025
• Primary Completion (Estimated): December 29, 2026
• Study Completion (Estimated): December 29, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)