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Trial Title:
Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology
NCT ID:
NCT06417190
Condition:
Muscle-Invasive Bladder Carcinoma
Tumor
Conditions: Official terms:
Urinary Bladder Neoplasms
Conditions: Keywords:
Trimodal Therapy (TMT)
Neoadjuvant Chemotherapy
muscle-invasive urothelial cell bladder cancer (MIBC)
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single-arm, open-label
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Trimodal therapy (TMT) within 45 days of neoadjuvant chemotherapy (NAC)
Description:
Single-arm, open-label
Arm group label:
Single Arm
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.
Detailed 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.
Criteria for eligibility:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cedars Sinai Medical Center
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Contact:
Last name:
Clinical Trial Recruitment Navigator
Phone:
310-423-2133
Email:
cancer.trial.info@cshs.org
Investigator:
Last name:
Leslie Ballas, MD
Email:
Principal Investigator
Investigator:
Last name:
Anirban Mitra, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Michael Ahdoor, MD
Email:
Sub-Investigator
Investigator:
Last name:
Charles Rosser, MD
Email:
Sub-Investigator
Start date:
July 2024
Completion date:
July 2030
Lead sponsor:
Agency:
Leslie Ballas
Agency class:
Other
Source:
Cedars-Sinai Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06417190
