Actively Recruiting
Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology
Led by Leslie Ballas · Updated on 2026-05-04
20
Participants Needed
1
Research Sites
254 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented diagnosis of muscle invasive bladder cancer with variant histology, cT2-T4N0M0, confirmed by TURBT and CT C/A/P and/or PET
- Written informed consent given and ability to follow study requirements
You will not qualify if you...
- Evidence of diffuse carcinoma in situ on pathology
- Presence of bilateral hydronephrosis (unilateral hydronephrosis allowed)
- Prior radiation therapy to the pelvis
- History of systemic therapy for muscle invasive bladder cancer
- Presence of concurrent cancer (patients with cancer history over 5 years ago without disease allowed)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
Research Team
C
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CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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