NRG-GU015

The Phase III Adaptive Radiation and Chemotherapy for Muscle Invasive Bladder Cancer Trial (ARCHER)

Principal Investigator

Scott Delacroix, MD

Co-Principal Investigator(s)

Himanshu Nagar, MD

Status

Disease Site

Genitourinary [GU] Bladder

Phase

III

Developmental Therapeutics

Yes

Primary Objective

Demonstrate non-inferiority of
ultra-hypofractionated (SBRT) compared to hypofractionated RT with a 10%
non-inferiority margin (from 50% to 40%) in the rate of bladder-intact
event-free survival (BI-EFS) at 3 years (corresponding to a hazard ratio
<1.32).

Patient Population

Patients with Histologically proven, cT2-T3,N0M0 urothelial carcinoma of the bladder prior to randomization.

 

Target Accrual

486