RECRUITING

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

Description

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 BladderMuscle Invasive Bladder Carcinoma
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Related Conditions:

Malignant Neoplasm of BladderMuscle Invasive Bladder Carcinoma

Study Overview

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Study Details

Study overview

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.

Phase II Trial on the Safety and Efficacy of Partial Cystectomy and Extended Pelvic Lymph Node Dissection With Standard of Care Perioperative Systemic Therapy in the Management of Muscle-Invasive Bladder Cancer (PRESERVE Trial)

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

Condition
Malignant Neoplasm of Bladder
Intervention / Treatment

-

Contacts and Locations

Cleveland

Glickman Urological and Kidney Institute, Cleveland Clinic, Case Comprehensive Cancer Center, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

19 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Case Comprehensive Cancer Center,

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

Study Record Dates

2027-01-29