Study on Preserving the Bladder in Patients with Muscle Invasive Bladder Cancer with Variant Histology
Sponsor: Leslie Ballas
ClinicalTrials ID:NCT06417190
This clinical trial is exploring a treatment approach for patients with muscle invasive bladder cancer (MIBC) that includes chemotherapy, with or without immunotherapy, followed by a combination of chemotherapy and radiation therapy. The study aims to see if this approach can be a viable option for patients at risk of cancer spreading.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is testing a treatment plan for patients with muscle invasive bladder cancer (MIBC) that has different cell types, known as variant histology. The treatment involves giving chemotherapy, with or without immunotherapy, before using a combination of chemotherapy and radiation therapy. This approach is called trimodal therapy (TMT). The goal is to see if this treatment can be completed within 45 days and if it is a good option for patients who might have cancer spreading to other parts of the body. The results will be compared to past cases of patients with a more common type of bladder cancer who received similar treatment.
Description
Trimodal therapy (TMT) is a treatment option for patients with muscle invasive bladder cancer (MIBC) that involves chemotherapy, radiation therapy, and surgery. This study focuses on patients whose cancer has different cell types, known as variant histology. These types can include squamous, glandular, micropapillary, sarcomatoid, small cell/neuroendocrine, plasmacytoid, and nested variants. These are rare and not well-studied. The study will look at how well TMT works for these patients, as there is limited information available. Patients will receive at least three cycles of chemotherapy, with or without immunotherapy, followed by a course of chemotherapy and radiation therapy. The study will compare these patients to those with a more common type of bladder cancer who have received similar treatment in the past.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of muscle invasive bladder cancer with variant histology, stages cT2-T4N0M0, confirmed by specific medical tests.
- Provide written informed consent and be able to follow the study requirements.
Exclusion Criteria
- Have widespread cancer in the bladder lining as shown by pathology.
- Have swelling in both kidneys (hydronephrosis); only one kidney can be affected.
- Have had previous radiation therapy to the pelvic area.
- Have had previous systemic therapy for muscle invasive bladder cancer.
- Have another active cancer (a past cancer over 5 years ago is allowed if there is no current evidence of disease).
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cedars Sinai Medical Center | 90048 | Los Angeles | California |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.