Clinical trial NCT02688348: Quality of Life After Bladder-Preservation Chemotherapy and Radiation Therapy in Patients With Muscle-Invasive Bladder Cancer
Official title: Prospective Study of Bladder-Preservation Chemo-Radiotherapy (Partial Bladder Hypo-fractionated Radiotherapy) for Patients With Muscle-Invasive Bladder Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Infiltrating Bladder Urothelial Carcinoma
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Establish QOL with validated tools for patients undergoing bladder-preservation chemo-radiation
timeFrame: From the date of study entry up to 5 years
Secondary outcomes:
measure: Quantify the rate of early and late grade 3 or higher GU or GI toxicity based on the CTCAE criteria
timeFrame: Up to 5 years
measure: Overall survival
timeFrame: From the date of study entry to the date of death, assessed up to 5 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Christopher King
role: PRINCIPAL_INVESTIGATOR
References: