NCT05700227

Daily Online Adaptive Short-Course Radiation Therapy and Concurrent Chemotherapy for Muscle-Invasive Bladder Cancer

Daily Online Adaptive Short-Course Radiation Therapy and Concurrent Chemotherapy for Muscle-Invasive Bladder Cancer: A Prospective Trial of an Individualized Approach for Reducing Bowel and Bladder Toxicity (ARTIA-Bladder)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Varian, a Siemens Healthineers Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is a single-arm, prospective, multi-center clinical trial designed to demonstrate that adaptive radiotherapy for muscle-invasive bladder cancer will translate into a decreased rate of acute (assessed weekly during chemo-radiotherapy) grade 3 or greater gastrointestinal/genitourinary toxicity compared with the historically reported rate for non-adaptive radiation therapy. The Common Terminology Criteria for Adverse Events (CTCAE) version 5 assessment tool will be utilized.

Conditions

• Muscle Invasive Bladder Urothelial Carcinoma

Interventions

Type	Name	Description
RADIATION	Daily Adaptive External Beam Radiation Therapy	Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.

Timeline

• Start date: 2023-02-02
• Primary completion: 2024-05-09
• Completion: 2024-05-09
• First posted: 2023-01-26
• Last updated: 2024-07-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study