Adaptive RADiation Therapy With Concurrent Sacituzumab Govitecan (SG) for Muscle Invasive Bladder Cancer
Status:
Not yet recruiting
Trial end date:
2027-10-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to examine the safety and tolerability of treatment with
concurrent Sacituzumab Govitecan (SG) and adaptive radiation therapy. The main objective is
to establish the safety, tolerability, and feasibility of bladder preservation therapy
treatment with concurrent SG and adaptive image-guided radiation therapy for participants
with localized MIBC. Participants will receive the study drug, SG, through an IV once weekly
on days 1 and 8 of each 21-day treatment cycle. The first cycle of SG will begin 21 days
prior to the scheduled start of radiation therapy. The second and third cycles of SG will be
given while the participant is receiving radiation therapy. Participants will be asked to
undergo computed tomography (CT) and magnetic resonance imaging (MRI) pre-and post-treatment.
Participation in the research will last up to 5 years, depending on treatment outcomes, with
a treatment period of 8 weeks and a study follow-up period of up to 2-5 years thereafter, and
a survival follow-up, with only phone call communication from years 3-5.