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BRIEF TITLE: Bladder-Preservation Chemo-Radiotherapy (Partial Bladder Hypo-fractionated Radiotherapy) for Patients With Muscle-Invasive Bladder Cancer

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


  • Org Study ID: 15-000496
  • Secondary ID: NCI-2015-01765,JCCCID556,15-000496,P30CA016042
  • NCT ID: NCT02688348
  • NCT Alias:
  • Sponsor: Jonsson Comprehensive Cancer Center - Other
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting April 22, 2015 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Establish QOL with validated tools for patients undergoing bladder-preservation chemo-radiation

Primary Outcome 1 - Time Frame: From the date of study entry up to 5 years

Condition:

  • Infiltrating Bladder Urothelial Carcinoma

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)
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Christopher King

Role: Principal Investigator

Affiliation: UCLA / Jonsson Comprehensive Cancer Center

Location

Facility Status Contact
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California 90095
United States
Recruiting Christopher R. King
424-259-8777
crking@mednet.ucla.edu