Bladder-Sparing Treatment for Bladder Cancer With Variant Cell Types
Tests chemotherapy followed by chemotherapy and radiation in adults with muscle-invasive bladder cancer.
Plain-language title generated from the registry record
Registry title: Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology
Key facts
- Where
- Los Angeles, United StatesSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with muscle invasive bladder cancer that has a variant (non-pure urothelial) cell type, who are having chemotherapy first, then chemotherapy with radiation to try to keep the bladder.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Muscle invasive bladder cancer with variant histology, stage cT2-T4N0M0, confirmed by TURBT and CT of chest, abdomen and pelvis and/or PET
- Earlier treatment
- Cannot have had earlier systemic therapy for muscle invasive bladder cancer or earlier radiation to the pelvis
Main reasons for not taking part
- Diffuse cis (carcinoma in situ) on pathology
- Fluid backup in both kidneys (bilateral hydronephrosis); only one side is allowed
- Earlier radiation to the pelvis
- Earlier systemic therapy for muscle invasive bladder cancer
- Another cancer at the same time (a cancer more than 5 years ago is allowed if there is no sign of disease)
Read by machine on 9 November 2026.
Where in United States
- Cedars-Sinai Medical CenterLos Angeles, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Leslie Ballas
- Trial code
- NCT06417190
- Record updated
- 6 August 2026
- Original 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.Read full original descriptionShow less
IIT2023-13-BALLAS-VHTMT: Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology
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.
Inclusion: 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.
Exclusion: 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); Evidence of diffuse cis on pathology; Presence of bilateral hydronephrosis (if hydronephrosis is present, can only be unilateral).