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

Jonsson Comprehensive Cancer Center

Status: Withdrawn

Conditions: Infiltrating Bladder Urothelial Carcinoma

Treatments: Other: Questionnaire Administration; Other: Quality-of-Life Assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT02688348

NCI-2015-01765 (Registry Identifier)

15-000496 (Other Identifier)

JCCCID556 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Ancillary-Correlative (late toxicity and QOL)

Other group

Description:

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.

Treatment:

Other: Quality-of-Life Assessment

Other: Questionnaire Administration