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

Tumor Clinical Trial

Official title:

IIT2023-13-BALLAS-VHTMT: Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06417190
• Other study ID #: IIT2023-13-BALLAS-VHTMT
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2024
• Est. completion date: July 2030

Study information

• Verified date: May 2024
• Source: Cedars-Sinai Medical Center
• Contact: Clinical Trial Navigator
• Phone: 3104232133
• Email: cancer.trial.info[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 2030
• Est. primary completion date: July 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Muscle-Invasive Bladder Carcinoma
• Tumor
• Urinary Bladder Neoplasms

Intervention

Drug:
• Trimodal therapy (TMT) within 45 days of neoadjuvant chemotherapy (NAC)
Single-arm, open-label

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Leslie Ballas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Progression free (<=T2) survival rates	To estimate progression free (<=T2) survival rates from TMT	3 year
Other	Metastasis-free survival	To estimate the metastasis-free survival of TMT	3 year
Other	Rate of salvage cystectomy	To estimate the rate of salvage cystectomy following TMT	3 year
Other	Blood and urine correlatives of clinical outcomes	To investigate blood and urine correlatives of clinical outcomes (Signatera and Oncuria)	3 year
Primary	Feasibility of initiating TMT	To evaluate the feasibility of initiating TMT within 45 days of completion of NAC - Feasibility will be defined as at least 17 study participants initiating TMT within 45 days of NAC	45 days
Secondary	3-year bladder intact event free survival (BIEFS)	To estimate 3-year bladder intact event free survival (BIEFS) in patients undergoing TMT for MIBC with VH-TMT	3 year