RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2025-02-18
Study Completion:2027-01-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06290687

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.

Ages Eligible for Study:19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Subjects must have unifocal or limited multifocal disease amenable to complete surgical resection with partial cystectomy, as judged by the treating urologic oncologist.
  3. * 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.
  4. * Performance status - Karnofsky Performance Status ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status Grade 0 or 1.
  5. * Subjects must have normal organ and marrow function as defined below:
  6. * Total bilirubin within normal limits
  7. * AST (SGOT) ≤ 2.5 X institutional upper limit of normal
  8. * ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
  9. * Bone marrow:
  10. * Absolute neutrophil count (ANC) ≥ 1,500/mm3
  11. * Platelet count ≥ 80,000/mm3, Hemoglobin ≥ 9.0 g/dL
  12. * Subjects must have the ability to understand and the willingness to sign a written informed consent document.
  13. * Subjects must have tumor less than or equal to 5 cm in largest dimension as assessed radiographically.
  14. * Treatment naive for MIBC.
  1. * Presence of hydronephrosis.
  2. * Presence of multifocal disease that is not amenable to complete resection with partial cystectomy.
  3. * Presence of distant carcinoma in situ.
  4. * Presence of clinical N+ or M+ disease.
  5. * Presence of cT4+ disease.
  6. * Non-urothelial histology.
  7. * Concurrent upper tract (ureter or renal pelvis) or urethral urothelial carcinoma.
  8. * Subjects who are not surgical candidates due to competing medical comorbidities or who refuse surgical treatment.
  9. * 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.

Contacts and Locations

Study Contact

Nima Almassi, MD
CONTACT
(216) 444-1825
almassn2@ccf.org

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Case Comprehensive Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-18
Study Completion Date2027-01-29

Study Record Updates

Study Start Date2025-02-18
Study Completion Date2027-01-29

Terms related to this study

Keywords Provided by Researchers

  • Partial cystectomy
  • Pelvic Lymph Node Dissection

Additional Relevant MeSH Terms

  • Malignant Neoplasm of Bladder
  • Muscle Invasive Bladder Carcinoma