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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: Recruiting Phase 1 study of Muscle-Invasive Bladder Carcinoma and Localized Muscle Invasive Bladder Urothelial Carcinoma, sponsored by Shilpa Gupta, MD.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To establish the safety, tolerability, and feasibility of bladder preservation therapy treatment with concurrent SG and adaptive image-guided radiation therapy for patients with localized MIBC. This will be assessed by estimating the rate of acute dose-limiting toxicities occurring during Cycles 2-3 of treatment.
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 |
What NCT05833867 shows while recruiting
NCT05833867 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 124-participant average among 14 other Muscle-Invasive Bladder Carcinoma trials with a reported enrollment target (84% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05833867's enrollment target sits among peer trials
20 13th of 14 higher than 1 of 14 other Muscle-Invasive Bladder Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Muscle-Invasive Bladder Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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