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NCT05833867 · ClinicalTrials.gov registry record · Phase 1
Adaptive RADiation Therapy With Concurrent Sacituzumab Govitecan (SG) for Muscle Invasive Bladder Cancer
A Phase 1 study of Muscle-Invasive Bladder Carcinoma and Localized Muscle Invasive Bladder Urothelial Carcinoma, sponsored by Shilpa Gupta, MD.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05833867 is a Phase 1 study of Muscle-Invasive Bladder Carcinoma and Localized Muscle Invasive Bladder Urothelial Carcinoma that is actively recruiting participants, run by Shilpa Gupta, MD. The registered enrollment target is 20 participants, below the 124-participant average among 14 other Muscle-Invasive Bladder Carcinoma trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05833867, a Phase 1 study of Muscle-Invasive Bladder Carcinoma and Localized Muscle Invasive Bladder Urothelial Carcinoma, is actively recruiting participants, sponsored by Shilpa Gupta, MD.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Sacituzumab govitecan
- RADIATION Adaptive Radiotherapy
Study Locations (1)
Ohio
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-04-01 |
| Est. Completion | 2027-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05833867
The ClinicalTrials.gov registry entry for NCT05833867 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 124-participant average among 14 other Muscle-Invasive Bladder Carcinoma trials with a reported enrollment target (84% lower). The listed sponsor is Shilpa Gupta, MD, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Muscle-Invasive Bladder Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Sacituzumab govitecan is the first listed.
NCT05833867 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT05833867 about?
NCT05833867 is a clinical study titled "Adaptive RADiation Therapy With Concurrent Sacituzumab Govitecan (SG) for Muscle Invasive Bladder Cancer". 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 ad...
What is the current status of trial NCT05833867?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2024-04-01. Estimated completion is 2027-10.
What conditions does trial NCT05833867 study?
This clinical trial studies the following conditions: Muscle-Invasive Bladder Carcinoma, Localized Muscle Invasive Bladder Urothelial Carcinoma.
What interventions are being tested in trial NCT05833867?
The interventions under investigation include: Sacituzumab govitecan (DRUG), Adaptive Radiotherapy (RADIATION).
Who is sponsoring clinical trial NCT05833867?
This trial is sponsored by Shilpa Gupta, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05833867 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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