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

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.

Conditions

Muscle-Invasive Bladder Carcinoma, Tumor

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Muscle-Invasive Bladder Carcinoma
Intervention / Treatment

-

Contacts and Locations

Los Angeles

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

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

  • * Documented diagnosis of MIBC with variant histology, cT2-T4N0M0, confirmed by TURBT and CT C/A/P and/or PET.
  • * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
  • * Evidence of diffuse cis on pathology
  • * Presence of bilateral hydronephrosis (if hydronephrosis is present, can only be unilateral)
  • * Prior radiotherapy to the pelvis
  • * History of systemic therapy for MIBS
  • * Presence of concurrent cancer (remote history of cancer (\>5 years) allowed if the patient is without evidence of disease)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Leslie Ballas,

Leslie Ballas, MD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

2030-09