Actively Recruiting
Bladder Preservation for Patients With Muscle Invasive Bladder Cancer With Variant Histology Using Neoadjuvant Chemotherapy with or without Immunotherapy Followed by Trimodal Therapy
Led by Leslie Ballas · Updated on 2026-05-04
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatment outcomes in patients with muscle invasive bladder cancer (MIBC) who have variant histology. This Phase II study aims to assess neoadjuvant chemotherapy (NAC) with or without immunotherapy (IO), followed by trimodal therapy (TMT), as a potential treatment option. Currently, data on TMT use in variant histology MIBC is limited, and this trial seeks to provide prospective information on its feasibility and effectiveness compared to historical controls with pure urothelial carcinoma. Participants will receive at least three cycles of NAC, with or without IO as chosen by their oncologist, followed by a four- or six-week course of concurrent chemotherapy and radiation therapy as part of TMT. The treatment plan includes transurethral resection of the bladder tumor (TURBT) followed by combined chemotherapy and radiation. The study is designed to test if TMT can be started within 45 days after NAC, offering a timely treatment approach for patients at risk of systemic disease spread. Throughout the study, participants will undergo evaluations including tumor staging confirmed by TURBT and imaging (CT or PET scans). Researchers will monitor the feasibility of starting TMT within 45 days after NAC and will track outcomes such as 3-year bladder intact event-free survival. Safety and treatment delivery will be closely observed during the study period. The total participation time includes the treatment phase and follow-up assessments to measure treatment success and patient outcomes.
CONDITIONS
Brief 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 (MIBC) with variant histology, cT2-T4N0M0, confirmed by TURBT and CT C/A/P and/or PET
- Written informed consent obtained from the participant
- Ability to comply with study requirements
You will not qualify if you...
- Evidence of diffuse carcinoma in situ on pathology
- Presence of bilateral hydronephrosis (unilateral hydronephrosis allowed)
- Prior radiotherapy to the pelvis
- History of systemic therapy for muscle invasive bladder cancer
- Presence of concurrent cancer (remote history allowed if more than 5 years ago and no evidence of disease)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 45 days
Participants receive chemotherapy before the main treatment to reduce tumor size.
Multiple visits for chemotherapy administration
Duration - Duration of concurrent chemotherapy and radiation therapy as per protocol
Participants undergo transurethral resection of bladder tumor (TURBT) followed by concurrent chemotherapy with radiation therapy.
Multiple visits for chemotherapy and radiation treatments
Trial Site Locations
Total: 1 location
1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
Research Team
C
Clinical Trial Navigator
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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