Purpose of this Study
Group 1: People in this group will get the usual chemotherapy and radiation treatment for this cancer. They will have radiation 5 days a week for 4 to 5 weeks. That means about 20 treatments in total.
Group 2: People in this group will get the usual chemotherapy and a new way of giving radiation. This way uses fewer treatments with a higher dose. They will have radiation up to 2 days a week for up to 4 weeks. That means about 5 treatments in total.
Who Can Participate?
Eligibility
To join this study, patients must have bladder cancer proven by a lab test. The cancer must be in stages called cT2 to T3 and must not have spread to the lymph nodes or other parts of the body. Before joining, patients need a surgery called TURBT to remove as much of the tumor as possible.
Patients also need scans of the chest, belly, and pelvis using CT or MRI to make sure the cancer has not spread. If any lymph nodes look big, they must be tested to show there is no cancer. Patients cannot have cancer that has spread or certain types of bladder cancer.
Patients must be 18 or older. They cannot have had radiation to the pelvis before. If they had other treatments, any side effects must be mostly gone.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The purpose of this study is to compare two ways of giving radiation along with the usual chemotherapy. One way gives a higher dose each time but fewer treatments in a shorter time. The other way gives a lower dose each time but more treatments over a longer time. Both ways give the same total amount of radiation. The shorter treatment might help you keep your bladder and stop the cancer from coming back or spreading.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
NRG-GU015: The Phase III Adaptive Radiation and Chemotherapy for Muscle Invasive Bladder Cancer Trial (Archer)
Principal Investigator
Paul
Koffer
Protocol Number
PRO00119265
NCT ID
NCT07097142
Phase
III
Enrollment Status
Open to Enrollment