Bladder preservation approach for patients with muscle-invasive bladder cancer and variant histology
IIT2023-13-BALLAS-VHTMT: Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology
This study is testing a new treatment plan for patients with a specific type of bladder cancer to see if combining chemotherapy and radiation can help them better than past treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06417190 on ClinicalTrials.gov |
What this trial studies
This Phase II interventional study evaluates the outcomes of patients with muscle-invasive bladder cancer (MIBC) that has variant histology. Participants will receive neoadjuvant chemotherapy, with or without immunotherapy, followed by trimodal therapy, which includes chemotherapy and radiation. The study aims to determine if this treatment can be effectively administered within 45 days of the initial chemotherapy, comparing results to historical controls with pure urothelial carcinoma. This research addresses a rare and understudied tumor type, focusing on improving treatment options for patients with variant histologies.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with muscle-invasive bladder cancer with variant histology, specifically those classified as cT2-T4N0M0.
Not a fit: Patients with diffuse carcinoma in situ, bilateral hydronephrosis, or those who have received prior pelvic radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a viable bladder preservation option for patients with variant histology MIBC, potentially improving their treatment outcomes.
How similar studies have performed: While there are limited retrospective studies on this topic, this study represents a novel prospective approach to treating variant histology MIBC.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Evidence of diffuse cis on pathology * Presence of bilateral hydronephrosis (if hydronephrosis is present, can only be unilateral) * 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)
Where this trial is running
Los Angeles, California
- Cedars Sinai Medical Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Leslie Ballas, MD — Cedars-Sinai Medical Center
- Study coordinator: Clinical Trial Navigator
- Email: GroupCancerTrialInformation@cshs.org
- Phone: 3104232133
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.