Quality of Life After Bladder-Preservation Chemotherapy and Radiation Therapy in Patients With Muscle-Invasive Bladder Cancer
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2019 |
| Start Date: | April 22, 2015 |
| End Date: | April 22, 2021 |
Prospective Study of Bladder-Preservation Chemo-Radiotherapy (Partial Bladder Hypo-fractionated Radiotherapy) for Patients With Muscle-Invasive Bladder Cancer
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.
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.
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.
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.
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)
We found this trial at
1
site
Los Angeles, California 90095
Principal Investigator: Christopher R. King
Phone: 424-259-8777
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