Quality of Life After Bladder-Preservation Chemotherapy and Radiation Therapy in Patients With Muscle-Invasive Bladder Cancer

Not Applicable

Withdrawn

• Conditions: Infiltrating Bladder Urothelial Carcinoma
• Interventions: Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT02688348
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief Summary

This research trial studies quality of life after bladder-preservation chemotherapy and radiation therapy (chemo-radiotherapy) in patients with bladder cancer that has spread into or through the muscle layer of the bladder (muscle-invasive bladder cancer). Bladder-preservation chemo-radiotherapy is a standard treatment for patients with muscle-invasive bladder cancer, however, chemo-radiotherapy may cause urinary tract, bowel, and sexual late side effects that negatively affect patients' quality of life. Studying quality-of-life in patients with muscle-invasive bladder cancer after chemo-radiotherapy may help identify the long-term side effects of treatment and may help plan the best treatment in the future and improve patients' quality of life.

Detailed Description

PRIMARY OBJECTIVES:

I. To study health-related quality of life (HRQoL, or QOL) for patients undergoing protocol-based bladder-preservation chemo-radiation.

OUTLINE:

Patients complete the European Organization for Research and Treatment for Cancer (EORTC) QLQ-Bladder Cancer Muscle Invasive (BLM-C30) at baseline, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter after completion of chemo-radiotherapy.

Study Timeline

• Study Start: 2015-04-22
• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-02-17
• Study First Posted: 2016-02-23
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28
• Status Verified: 2020-02
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Histologically confirmed muscle-invasive urothelial cancer (no histology will be excluded)
• No pelvic nodal metastases or distant metastases (based on computed tomography [CT], positron emission tomography [PET] or magnetic resonance imaging [MRI])
• Karnofsky performance status (KPS) >= 70
• Ability to understand, and willingness to sign, the written informed consent
• Patient will have either opted for bladder-sparing treatment as compared to radical cystectomy, or deemed medically inoperable
• Following the recent recommendations from the International Consultation on Urological Diseases-European Association of Urology International Consultation on Bladder Cancer, eligible patients will be those with no hydronephrosis, no extensive carcinoma in situ (CIS), and no tumor invasion into the stroma of the prostate

Exclusion Criteria

• Patients with any evidence of distant metastases
• Prior pelvic radiotherapy
• History of Crohn's disease or ulcerative colitis
• Unable to receive chemotherapy
• Histologies other than urothelial (eg. squamous cell carcinoma, adenocarcinoma, small cell)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ancillary-Correlative (late toxicity and QOL)	Quality-of-Life Assessment	Patients complete the EORTC QLQ-BLM-C30 at baseline, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter after completion of chemo-radiotherapy.
Ancillary-Correlative (late toxicity and QOL)	Questionnaire Administration	Patients complete the EORTC QLQ-BLM-C30 at baseline, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter after completion of chemo-radiotherapy.

Primary Outcome Measures

Name	Time	Method
Establish QOL with validated tools for patients undergoing bladder-preservation chemo-radiation	From the date of study entry up to 5 years	Validated Quality-of-Life questionnaires developed by the European Organization for Research and Treatment for Cancer (EORTC) will be used. The EORTC QLQ-BLM30 with 30 questions specific to muscle-invasive bladder cancer will be combined and used in conjunction with the general cancer questionnaire EORTC QLQ-C30 (Aaronson).

Secondary Outcome Measures

Name	Time	Method
Quantify the rate of early and late grade 3 or higher GU or GI toxicity based on the CTCAE criteria	Up to 5 years
Overall survival	From the date of study entry to the date of death, assessed up to 5 years

Trial Locations

Locations (1)

UCLA / Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States