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NCT05254327 · ClinicalTrials.gov registry record · Phase 2
Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001
A Phase 2 study of Rectal Cancer, sponsored by University of Nebraska.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 118
- Enrollment target
- 3
- Study locations
NCT05254327: Recruiting Phase 2 study of Rectal Cancer, sponsored by University of Nebraska.
NCT05254327 is a Phase 2 study of Rectal Cancer that is actively recruiting participants, run by University of Nebraska. The registered enrollment target is 118 participants, below the 3,165-participant average among 70 other Rectal Cancer trials with a reported enrollment target (96% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05254327, a Phase 2 study of Rectal Cancer, is actively recruiting participants, sponsored by University of Nebraska.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 118 participants
- Enrollment target
- 3
- Study locations
Study Summary
In this Phase 2 study, we will conduct an efficacy and safety study of the combination of investigational drug BMX-001, with short-course radiotherapy (SCRT) or long-course chemoradiotherapy (LCCRT) as part of total neoadjuvant therapy in newly diagnosed rectal adenocarcinoma (RAC) patients.
Primary Outcome
Grade 3 and above radiation-associated gastrointestinal, genitourinary, skin and hematologic toxicity (SCRT or LCCRT) including frequency, severity and duration of rectal bleeding, rectal pain, diarrhea, dysuria, hematuria, urinary frequency, radiation dermatitis and thrombocytopenia
Conditions Studied
Interventions
- DRUG BMX-001
Study Locations (3)
Kentucky
- Markey Cancer Center - Lexington
Nebraska
- University of Nebraska Medical Center - Omaha
Texas
- UT Health San Antonio MD Anderson Cancer Center - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2022-08-15 |
| Est. Completion | 2029-06 |
| Phase | Phase 2 |
What NCT05254327 shows while recruiting
NCT05254327 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 3,165-participant average among 70 other Rectal Cancer trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Rectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which BMX-001 is the first listed.
NCT05254327 reports a single indexed study location in Kentucky, Nebraska, Texas.
Frequently Asked Questions
What is clinical trial NCT05254327 about?
NCT05254327 is a clinical study titled "Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001". In this Phase 2 study, we will conduct an efficacy and safety study of the combination of investigational drug BMX-001, with short-course radiotherapy (SCRT) or long-course chemoradiotherapy (LCCRT) as part of total neoadjuvant therapy in newly diagnosed rectal adenocarcinoma (RAC) patients.
What is the current status of trial NCT05254327?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2022-08-15. Estimated completion is 2029-06.
What conditions does trial NCT05254327 study?
This clinical trial studies the following conditions: Rectal Cancer.
What interventions are being tested in trial NCT05254327?
The interventions under investigation include: BMX-001 (DRUG).
Who is sponsoring clinical trial NCT05254327?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05254327 being conducted?
This trial has 3 study locations across Kentucky, Nebraska, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Rectal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05254327's enrollment target sits among peer trials
118 22nd of 70 higher than 49 of 70 other Rectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rectal Cancer 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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