Actively Recruiting
Adaptive Radiation Therapy With Concurrent Sacituzumab Govitecan for Bladder Preservation in Patients With Muscle-Invasive Bladder Cancer
Led by Shilpa Gupta, MD · Updated on 2026-03-13
20
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
Sponsors
S
Shilpa Gupta, MD
Lead Sponsor
V
Varian Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the safety, tolerability, and feasibility of combining Sacituzumab Govitecan (SG), an investigational antibody drug conjugate, with adaptive image-guided radiation therapy for bladder preservation in participants with localized muscle-invasive bladder cancer (MIBC) who are ineligible for or refuse standard treatments like radical cystectomy or conventional chemotherapy. The study focuses on platinum-ineligible patients and explores a bladder-sparing approach using targeted therapy alongside radiation. Participants will receive SG intravenously at a dose of 8 mg/kg in 21-day treatment cycles, with doses given weekly on days 1 and 8. The first cycle of SG starts 21 days before radiation therapy, and two more cycles are administered concurrently with adaptive radiotherapy tailored to each participant. This approach aims to combine the targeted drug with personalized radiation therapy over an 8-week treatment period. During the study, participants will undergo CT and MRI scans before and after treatment to monitor response. Researchers will assess safety by tracking acute dose-limiting toxicities within 6 months and evaluate bladder intact event-free survival over 2 years. Follow-up can last up to 5 years, including phone-based communication from years 3 to 5. The study involves regular assessments of organ function, performance status, and bladder health to ensure participant safety and treatment feasibility throughout the trial.
CONDITIONS
Brief Title
Adaptive RADiation Therapy With Concurrent Sacituzumab Govitecan (SG) for Muscle Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have histologically or cytologically confirmed muscle-invasive bladder cancer (T2-T4aN0M0).
- Participants with mixed urothelial carcinoma are eligible except those with small cell or neuroendocrine components.
- No prior systemic chemotherapy for this disease.
- Participants must refuse conventional radio-sensitizing chemotherapy or be ineligible for or refuse cystectomy.
- ECOG Performance status of 2 or less.
- Normal organ and marrow function as defined by specific laboratory values.
- Adequate baseline bladder function without bilateral hydronephrosis or acute obstruction after TURBT.
- Underwent TURBT within 60 days prior to treatment start.
- Radiological staging with CT or MRI of chest, abdomen, and pelvis within 60 days prior to treatment.
- No evidence of T4b and/or N1-3 disease.
- No urothelial carcinoma or variant histology outside bladder within previous 24 months except certain upper urinary tract conditions.
- Ability to understand and willingness to sign informed consent.
You will not qualify if you...
- Receiving or using other investigational agents or devices.
- Prior pelvic or local radiation therapy for muscle-invasive bladder cancer or other cancers.
- Prior systemic treatment, chemoradiation, or radiation therapy for muscle-invasive or non-muscle-invasive bladder cancer (except certain intravesical therapies).
- Diagnosed bilateral hydronephrosis.
- Limited bladder function requiring catheterization or permanent indwelling catheter.
- History of allergic reactions to Sacituzumab Govitecan or similar compounds.
- Uncontrolled illnesses or conditions that limit study compliance.
- Pregnant or breastfeeding women.
- Participation in another investigational study or use of investigational device within 4 weeks prior to study intervention.
- Any condition or abnormality that may interfere with study participation or results, as per investigator's opinion.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants must undergo radiological staging with CT or MRI and receive laboratory tests to confirm eligibility.
Duration - 21 days
Participants receive 1 loading cycle of Sacituzumab Govitecan prior to starting radiation therapy.
2 intravenous infusions on Day 1 and Day 8
Duration - Approximately 6 to 7 weeks
Participants receive concurrent adaptive image-guided radiation therapy along with two subsequent 21-day cycles of Sacituzumab Govitecan.
Intravenous infusions on Day 1 and Day 8 of each cycle with concurrent radiation therapy sessions as per individualized plan
Duration - Up to 2 years
Participants are monitored for safety, toxicity, and bladder intact event-free survival after treatment completion.
Regular follow-up visits to assess health status and bladder function
Trial Site Locations
Total: 1 location
1
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
S
Shilpa Gupta, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here