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

Infiltrating Bladder Urothelial Carcinoma Clinical Trial

Official title:

Prospective Study of Bladder-Preservation Chemo-Radiotherapy (Partial Bladder Hypo-fractionated Radiotherapy) for Patients With Muscle-Invasive Bladder Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02688348
• Other study ID #: 15-000496
• Secondary ID: NCI-2015-01765JC
• Status: Withdrawn
• Phase: N/A
• Start date: April 22, 2015
• Est. completion date: February 28, 2019

Study information

• Verified date: February 2020
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell
• Infiltrating Bladder Urothelial Carcinoma
• Urinary Bladder Neoplasms

Intervention

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish QOL with validated tools for patients undergoing bladder-preservation chemo-radiation	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).	From the date of study entry up to 5 years
Secondary	Quantify the rate of early and late grade 3 or higher GU or GI toxicity based on the CTCAE criteria		Up to 5 years
Secondary	Overall survival		From the date of study entry to the date of death, assessed up to 5 years