NCT02716896

Radical Cystectomy Compared With Chemoradiation for Muscle Invasive Bladder Cancer

Radical Cystectomy Compared With Chemoradiation for Muscle Invasive Bladder Cancer: A Pilot, Randomized-Controlled Non-Inferiority Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Muscle Invasive Bladder Cancer

Interventions

Type	Name	Description
RADIATION	Radiation and chemoradiation	Radiation and chemotherapy will be administered concurrently to those who are randomized to this group.
PROCEDURE	Radical cystectomy	Radical cystectomy will be performed on those who are randomized to this group.

Timeline

• Start date: 2016-05-01
• Primary completion: 2018-03-26
• Completion: 2018-03-26
• First posted: 2016-03-23
• Last updated: 2019-11-25
• Results posted: 2019-11-12

Locations

1 site across 1 country: United States