Prediction of Impaired Survival in Elderly Bladder Cancer Patients Opting for Radical Cystectomy

Completed

• Conditions: Bladder Cancer

• Registration Number: NCT02039310
• Lead Sponsor: University of Michigan

Brief Summary

The investigators proposes a prospective cohort study in patients with high risk bladder cancer who have opted for radical cystectomy. The investigators aim to correlate pre-operative measures of body composition, cognitive and functional status with impaired survival at 6 months after cystectomy. Impairment in this context will be a compilation of several specific objective measures including: 1) death from any cause, 2) major complication (Clavien score7 ≥ 3), 3) loss of independent living status, 4) performance status, and 5) global well-being. The study team believes that Impairment Free Survival is an important endpoint as it accounts for many aspects of a patient's functional status that might alter a patient's choice to proceed with radical surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2014-01-15
• Study First Submitted QC: 2014-01-16
• Study First Posted: 2014-01-17
• Primary Completion: 2015-12-31
• Study Completion: 2015-12-31
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-25
• Last Update Posted: 2017-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Histologic diagnosis of bladder carcinoma (any histology permitted)
• Planned treatment with radical cystectomy.
• Age 65 years or older at the time of radical cystectomy
• Able to give consent
• Neoadjuvant chemotherapy is permissible
• Prior malignancy is permissible, without evidence of disease for at least 2 years
• Concomitant localized prostate cancer, skin cancer, and in situ malignancies are permissible.
• Willingness to complete surgical follow-up at the University of Michigan for at least 6 months after radical cystectomy.

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Exclusion Criteria

• Evidence of metastatic bladder cancer
• Life expectancy less than one year
• Concurrent treatment on another clinical trial. Non-intervention supportive care trials or non-treatment trials, e.g. QOL, are allowed

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impairment Free Survival	6 months	Impairment-free survival is defined as the time from radical cystectomy to the identification of: 1) major complication (Clavien score7 ≥ 3), 2) loss of independent living status, 3) ECOG performance status ≥ 3 beyond 4 weeks from RC, 4) global well-being or 5) death from any cause. Patients who drop-out before the 6-month end of study and who have not had an impairment event will be censored at their time of drop-out.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States