Bladder Preservation for Patients with Muscle Invasive Bladder Cancer (MIBC) with Variant Histology

Last updated: March 3, 2025
Sponsor: Leslie Ballas
Overall Status: Active - Recruiting

Phase

2

Condition

Bladder Cancer

Urothelial Cancer

Carcinoma

Treatment

Trimodal therapy (TMT) within 45 days of neoadjuvant chemotherapy (NAC)

Clinical Study ID

NCT06417190
IIT2023-13-BALLAS-VHTMT
  • Ages > 18
  • All Genders

Study Summary

This is a Phase II, single cohort study designed to evaluate outcomes in patients with muscle invasive bladder cancer (MIBC) with variant histology who receive neoadjuvant chemotherapy (NAC) with or without immunotherapy (IO) followed by trimodal therapy (TMT). Enrolled patients will undergo at least 3 cycles of NAC +/- IO (oncologist's choice) followed by a four- or six-week course of concurrent standard of care chemotherapy and radiation therapy. These patients will be compared with historical controls of patients with a diagnosis of pure urothelial carcinoma who have undergone TMT. This study has been designed to test the hypothesis that variant histology TMT can be delivered within 45 days of NAC +/- IO and is therefore a viable option in patients who are risk of systemic disease spread.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documented diagnosis of MIBC with variant histology, cT2-T4N0M0, confirmed by TURBTand CT C/A/P and/or PET.

  • Written informed consent obtained from subject and ability for subject to complywith the requirements of the study.

Exclusion

Exclusion Criteria:

  • Evidence of diffuse cis on pathology

  • Presence of bilateral hydronephrosis (if hydronephrosis is present, can only beunilateral)

  • Prior radiotherapy to the pelvis

  • History of systemic therapy for MIBS

  • Presence of concurrent cancer (remote history of cancer (>5 years) allowed if thepatient is without evidence of disease)

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Trimodal therapy (TMT) within 45 days of neoadjuvant chemotherapy (NAC)
Phase: 2
Study Start date:
March 01, 2025
Estimated Completion Date:
September 30, 2030

Study Description

Trimodal therapy (TMT) is accepted as an NCCN category 1 alternative to radical cystectomy (with neoadjuvant chemotherapy) in patients with cT2N0M0 muscle-invasive urothelial cell bladder cancer (MIBC). Not all patients with MIBC have pure urothelial cell carcinoma; urothelial carcinoma with variant histology (VH) described any morphologic variant of conventional urothelial carcinoma that is believed to be derived from urothelial carcinoma and is typically admixed with conventional urothelial carcinoma in the same tumor. Variant histologies described include squamous differentiation, glandular differentiation, micropapillary, sarcomatoid, small cell/neuroendocrine, plasmacytoid and nested variant. This is a rare tumor type and understudied. For patients with variant histologies there is limited data on the use of trimodal therapy. There are a couple single institution retrospective studies and data from the NCDB, but no prospective data.

Connect with a study center

  • Cedars Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

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