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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01765 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| JCCCID556 | Other Identifier | Jonsson Comprehensive Cancer Center | |
| 15-000496 | Other Identifier | UCLA / Jonsson Comprehensive Cancer Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ancillary-Correlative (late toxicity and QOL) | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality-of-Life Assessment | Other | Ancillary studies |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quantify the rate of early and late grade 3 or higher GU or GI toxicity based on the CTCAE criteria | Up to 5 years | |
| Overall survival | From the date of study entry to the date of death, assessed up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher King | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
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| Questionnaire Administration | Other | Ancillary studies |
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