RECRUITING

Bladder Preservation for Patients with Muscle Invasive Bladder Cancer (MIBC) with Variant Histology

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

This is a Phase II, single cohort study designed to evaluate outcomes in patients with muscle invasive bladder cancer (MIBC) with variant histology who receive neoadjuvant chemotherapy (NAC) with or without immunotherapy (IO) followed by trimodal therapy (TMT). Enrolled patients will undergo at least 3 cycles of NAC +/- IO (oncologist's choice) followed by a four- or six-week course of concurrent standard of care chemotherapy and radiation therapy. These patients will be compared with historical controls of patients with a diagnosis of pure urothelial carcinoma who have undergone TMT. This study has been designed to test the hypothesis that variant histology TMT can be delivered within 45 days of NAC +/- IO and is therefore a viable option in patients who are risk of systemic disease spread.

Official Title

IIT2023-13-BALLAS-VHTMT: Bladder Preservation for Patients with Muscle Invasive Bladder Cancer (MIBC) with Variant Histology

Quick Facts

Study Start:2025-03-01
Study Completion:2030-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06417190

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented diagnosis of MIBC with variant histology, cT2-T4N0M0, confirmed by TURBT and CT C/A/P and/or PET.
  2. * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
  1. * Evidence of diffuse cis on pathology
  2. * Presence of bilateral hydronephrosis (if hydronephrosis is present, can only be unilateral)
  3. * Prior radiotherapy to the pelvis
  4. * History of systemic therapy for MIBS
  5. * Presence of concurrent cancer (remote history of cancer (\>5 years) allowed if the patient is without evidence of disease)

Contacts and Locations

Study Contact

Clinical Trial Navigator
CONTACT
3104232133
cancer.trial.info@cshs.org

Principal Investigator

Leslie Ballas, MD
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center

Study Locations (Sites)

Cedars Sinai Medical Center
Los Angeles, California, 90048
United States

Collaborators and Investigators

Sponsor: Leslie Ballas

  • Leslie Ballas, MD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical 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 Date2025-03-01
Study Completion Date2030-09

Study Record Updates

Study Start Date2025-03-01
Study Completion Date2030-09

Terms related to this study

Keywords Provided by Researchers

  • Trimodal Therapy (TMT)
  • Neoadjuvant Chemotherapy
  • muscle-invasive urothelial cell bladder cancer (MIBC)

Additional Relevant MeSH Terms

  • Muscle-Invasive Bladder Carcinoma
  • Tumor