A Study to Evaluate Treatment Preferences for Japanese Participants With Muscle-invasive Urothelial Carcinoma of the Bladder

NCT05742867 | Completed

• 1 other identifier: CA209-6M4
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to identify important treatment attributes for post-radical cystectomy (RC) treatment for participants with MIBC (Muscle-Invasive Bladder Cancer) and assess the relative importance of treatment attributes for post-RC treatment in Japan.

Conditions

Urinary Bladder Neoplasms

Outcome Measures

Primary Outcomes (11)

• Overall survival

  Median overall survival (years)

  Up to 1 year after radical cystectomy

• 5-year survival rate

  Defined as the percentage of patients that are alive after 5 years

  Up to 1 year after radical cystectomy

• Disease-free survival (DFS)

  Median disease-free survival (year)

  Up to 1 year after radical cystectomy

• Probability of side effect-related treatment discontinuation

  Defined as the percent likelihood that a patient will stop treatment due to a side effect

  Up to 1 year after radical cystectomy

• Number of participants who experience treatment side effects

  Defined as the percentage of participants who experience nausea, diarrhea, fatigue, skin-related side effects (e.g. pruritus, rash), endocrine system-related side effects (e.g. hypothyroidism), anemia, alopecia, reduced renal function, cardiac impairment, leukopenia, neutropenia, and thrombocytopenia due to treatment

  Up to 1 year after radical cystectomy

• Overall severity of side effects

  Defined as the severity of side effects categorized as "None", "mild-to-moderate", or "severe"

  Up to 1 year after radical cystectomy

• Treatment Convenience

  Defined as the route of administration and frequency of administration per day or week (Infusions once every week, 2 weeks, or 4 weeks)

  Up to 1 year after radical cystectomy

• Treatment duration

  Defined as the total duration for continuous administration of treatment categorized as 2 months, 4 months, or 1 year

  Up to 1 year after radical cystectomy

• Hospitalization

  Defined as the length of hospitalization required for administration of treatment categorized as 0 days (no hospitalization required for administration of treatment), 1 week, or more than 1 week

  Up to 1 year after radical cystectomy

• Frequency of outpatient consultations

  Defined as the number of outpatient consultations required for treatment administration and monitoring categorized as every 2 weeks, 4 weeks, or 3 months

  Up to 1 year after radical cystectomy

• Annual treatment costs

  Defined as the annual out-of-pocket treatment costs, categorized as 10,000, 300,000, or 650,000 JPY

  Up to 1 year after radical cystectomy

Study Arms (1)

Cohort 1

High-risk Muscle-Invasive Bladder Cancer (MIBC) participants following radical cystectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population is composed of 115 Japanese participants, 18 years and older, with muscle-invasive urothelial carcinoma of the bladder following radical cystectomy.

You may qualify if:

• Must reside in Japan and able to speak/read Japanese for the interview/survey
• Must have a clinical diagnosis of Muscle-invasive bladder cancer (MIBC):
• ypT2-ypT4a or ypN+ MIBC, with prior neoadjuvant cisplatin chemotherapy and underwent radical cystectomy
• pT3-pT4a or pN+ MIBC, without prior neoadjuvant cisplatin chemotherapy and underwent radical cystectomy
• Must not have received any treatment related to MIBC after radical cystectomy

You may not qualify if:

• Determined by the physician as being unsuitable for the study (e.g. having any clinically significant psychiatric disorder, cognitive impairment, or having difficulty with communicating in Japanese)
• Confirmed diagnosis of other primary cancers at the time of obtaining consent
• Current participation in a MIBC clinical trial

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Ono Pharmaceutical Co. Ltd: collaborator

Study Sites (1)

Local Institution - 0001

Morrisville, North Carolina, 27560, United States

Location

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 24, 2023
• Study Start: May 31, 2023
• Primary Completion: July 10, 2024
• Study Completion: July 10, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

US (1)