Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05833867

Adaptive RADiation Therapy With Concurrent Sacituzumab Govitecan (SG) for Muscle Invasive Bladder Cancer

Led by Shilpa Gupta, MD · Updated on 2026-03-13

20

Participants Needed

1

Research Sites

182 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

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.

CONDITIONS

Official Title

Adaptive RADiation Therapy With Concurrent Sacituzumab Govitecan (SG) for Muscle Invasive Bladder Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed muscle-invasive bladder cancer (T2-T4aN0M0), including mixed urothelial carcinoma except small cell or neuroendocrine types
  • No prior systemic chemotherapy for this disease
  • Refusal of conventional radio-sensitizing chemotherapy or ineligibility for cystectomy; cystectomy allowed after treatment if needed
  • ECOG performance status of 2 or less
  • Normal organ and marrow function as defined by specific laboratory values (AST/ALT ≤ 2.5 x ULN, bilirubin ≤ 2.0 x ULN, ANC ≥ 1500/µL, platelets ≥ 100,000/µL, hemoglobin ≥ 9.0 g/dL, calcium ≤ 12.0 mg/dL, creatinine clearance ≥ 30 mL/min)
  • Adequate baseline bladder function without bilateral hydronephrosis or acute obstruction after TURBT; unilateral hydronephrosis allowed
  • Underwent TURBT within 60 days before treatment start; repeat cystoscopy or TURBT allowed if necessary
  • Tumors may be completely or partially resected with maximal resection attempted
  • Radiological staging (CT or MRI of chest, abdomen, pelvis) within 60 days before treatment start showing no T4b or N1-3 disease
  • No urothelial carcinoma outside the bladder in previous 24 months except certain upper urinary tract cases after nephroureterectomy
  • Ability and willingness to provide informed consent
Not Eligible

You will not qualify if you...

  • Use of other investigational agents or devices
  • Prior pelvic or local radiation therapy for bladder cancer or other cancer
  • Prior systemic treatment, chemoradiation, or radiation therapy for MIBC or non-muscle-invasive bladder cancer (except intravesical therapy)
  • Bilateral hydronephrosis
  • Limited bladder function requiring self-catheterization or permanent catheter
  • History of allergic reactions to compounds similar to Sacituzumab Govitecan
  • Uncontrolled illnesses such as active infection, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
  • Pregnant or breastfeeding women
  • Participation in another investigational study or use of investigational device within 4 weeks before study intervention
  • Any condition or laboratory abnormality that may interfere with study participation or outcomes as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States, 44195

Actively Recruiting

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Research Team

S

Shilpa Gupta, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Adaptive RADiation Therapy With Concurrent Sacituzumab Govitecan (SG) for Muscle Invasive Bladder Cancer | DecenTrialz