Currently the standard treatment of muscle invasive bladder cancer is the complete removal of bladder and adjacent organs, such as prostate or ovaries. Radical cystectomy is fraught with complications and risk of death. The researchers hope to learn if chemoradiation (i.e. using chemotherapy and radiation), also an acceptable treatment for muscle invasive bladder cancer, can be used a good alternative therapy option.
Currently the standard treatment of muscle invasive bladder cancer is the complete removal of bladder and adjacent organs, such as prostate or ovaries. Such procedure is highly invasive and undesirable for some patients. The researchers hope to learn if chemoradiation, using chemotherapy and radiation, can be a good alternative therapy option. Chemoradiation therapy is also currently considered an acceptable clinical approach but is typically used for treatment in patients with muscle invasive bladder cancer who have other medical issues that might cause complications during or after undergoing surgery. Disease free survival at 5 years is better for those who had their bladder removed, but overall survival rates for chemoradiation therapy patients are comparable between the two approaches.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Radiation and chemotherapy will be administered concurrently to those who are randomized to this group.
Radical cystectomy will be performed on those who are randomized to this group.
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Total Number of Participants Adhere to the Assigned Treatment
Number of randomized participants that progressed to one year on treatment
Time frame: One year
Total Number of Participants Withdraw From the Study
Number of randomized participants who were withdrawn from the study by the investigator, or who voluntarily withdrew
Time frame: One year
Total Number of Participants Completed the Study
Number of randomized subjects who completed the study to one year
Time frame: One year
Change From Baseline and Year 1 in Health Related Quality of Life Measures
Questionnaires such as FACT-Bl (functional assessment of cancer therapyfor patients with bladder cancer), Katz ADL (Katz Index of Independence in Activities of Daily Living), and EORTC (European Organization for Research and Treatment of Cancer), all surveys used to assess quality of life, will be used to measure the changes.
Time frame: One year
Total Number of Participants Who Are Able to Keep Their Bladder Within the Time Frame of the Study
Number of participants that were randomized who did not have bladder cystectomy during the one year study period
Time frame: One year
Total Number of Participants Who Remained Progression-free Within the Time Frame of the Study
Number of participants who completed the study whose disease state did not worsen during participation
Time frame: One year
Change From Baseline Level to Year 1 on Genomic Markers After Chemoradiation
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Genomic markers will be isolated from the research biological samples, and then measured by tissue RNA microarray.
Time frame: One year