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Bladder Preservation for Muscle Invasive Bladder Cancer

Phase 2
Waitlist Available
Led By Leslie Ballas, MD
Research Sponsored by Leslie Ballas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented diagnosis of MIBC with variant histology, cT2-T4N0M0, confirmed by TURBT and CT C/A/P and/or PET
Be older than 18 years old
Must not have
Evidence of diffuse cis on pathology
Prior radiotherapy to the pelvis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 year
Awards & highlights

Summary

"This trial aims to see if giving a combination of chemotherapy and immunotherapy before standard treatment can be a successful option for patients with a specific type of bladder cancer. Patients will receive neoadjuvant chemotherapy

Who is the study for?
This trial is for patients with a specific type of bladder cancer called Muscle Invasive Bladder Cancer (MIBC) that has unusual cell types (variant histology). Participants must have completed at least 3 cycles of chemotherapy, with or without immunotherapy, and be ready to undergo trimodal therapy combining chemo and radiation.
What is being tested?
The study is testing if a combination treatment approach for MIBC with variant histology—chemo followed by chemoradiation—is effective when started within 45 days after initial chemo. It compares these patients' outcomes to past patients who had standard bladder cancer treated similarly.
What are the potential side effects?
Possible side effects include those from chemotherapy such as nausea, hair loss, fatigue; from radiation like skin irritation, discomfort during urination; and from immunotherapy which can involve immune-related reactions affecting various organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My bladder cancer is invasive but hasn't spread beyond the bladder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My pathology report shows widespread abnormal cells.
Select...
I have had radiation treatment to my pelvic area.
Select...
I have had systemic therapy for muscle-invasive bladder cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of initiating TMT
Secondary study objectives
3-year bladder intact event free survival (BIEFS)
Other study objectives
Blood and urine correlatives of clinical outcomes
Metastasis-free survival
Progression free (<=T2) survival rates
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Neoadjuvant chemotherapy followed by trimodal therapy consisting of TURBT followed by concurrent chemotherapy with radiation therapy

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Who is running the clinical trial?

Leslie BallasLead Sponsor
Leslie Ballas, MDPrincipal InvestigatorCedars-Sinai Medical Center
1 Previous Clinical Trials
100 Total Patients Enrolled
~13 spots leftby Jul 2030
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