Bladder preservation approach for patients with muscle-invasive bladder cancer and variant histology

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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: 310-423-5842

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Assessing late images in PET-CT for bladder cancer staging

  This study is testing if taking later images during a PET-CT scan can help better identify lymph node involvement in patients with muscle-invasive bladder cancer.

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• Neoadjuvant chemotherapy followed by watchful waiting versus immediate bladder treatment for muscle-invasive bladder cancer

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  Recruiting Phase 2/3 University of British Columbia · Vancouver, British Columbia · NCT06537154

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.