NCT01520038

Adjuvant Proton Therapy or IMRT for the Treatment of Bladder Cancer

Feasibility and Phase 1/II Trial of Adjuvant Radiation Therapy for the Treatment of Urothelial Bladder Cancer Using Proton Therapy or IMRT

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Invasive urothelial bladder cancer is a common malignancy causing 14,000 deaths annually in the United States. The primary objective of the feasibility/Phase I portion of the study is to establish the feasibility and safety of proton and the safety of IMRT for patients with pure or mixed variant urothelial carcinoma.

Detailed description

Invasive urothelial bladder cancer is a common malignancy causing 14,000 deaths annually in the United States. The primary objective of the feasibility/Phase I portion of the study is to establish the feasibility and safety of proton and the safety of IMRT. Safety will be based on acute toxicity. The primary objective of the phase II study is to generate estimates of the local failure rate for intermediate and high risk patients treated with either proton therapy or IMRT. The study, however, is not explicitly designed to compare outcomes of proton therapy and IMRT. Secondary objectives include further evaluation of acute and late toxicity, quality of life and estimation of overall survival.

Conditions

• Urothelial Carcinoma of the Bladder

Interventions

Type	Name	Description
RADIATION	Proton therapy
RADIATION	IMRT

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-01-27
• Last updated: 2019-11-26
• Results posted: 2019-11-26

Locations

1 site across 1 country: United States