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NCT05412082 · ClinicalTrials.gov registry record · Phase 1
SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer
A Phase 1 study of Locally Advanced Rectal Cancer, sponsored by University of Miami.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT05412082: Recruiting Phase 1 study of Locally Advanced Rectal Cancer, sponsored by University of Miami.
NCT05412082 is a Phase 1 study of Locally Advanced Rectal Cancer that is actively recruiting participants, run by University of Miami. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05412082, a Phase 1 study of Locally Advanced Rectal Cancer, is actively recruiting participants, sponsored by University of Miami.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to find out how safe and effective is treating patients with locally advanced rectal cancer (LARC) with chemotherapy first and then follow with radiation therapy to a higher dose than what is usually delivered and see if patients could have complete response and be spared from surgery.
Primary Outcome
Reported as the incidence of toxicity (adverse events and serious adverse events) in study participants after start of MRI-g Pelvic ART. Toxicity in study participants will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG 5-fluorouracil
- RADIATION Intensity-modulated radiation therapy
Study Locations (1)
Florida
- University of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2022-10-05 |
| Est. Completion | 2028-10-31 |
| Phase | Phase 1 |
What NCT05412082 shows while recruiting
NCT05412082 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Locally Advanced Rectal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Capecitabine is the first listed.
NCT05412082 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05412082 about?
NCT05412082 is a clinical study titled "SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer". The purpose of this research study is to find out how safe and effective is treating patients with locally advanced rectal cancer (LARC) with chemotherapy first and then follow with radiation therapy to a higher dose than what is usually delivered and see if patients could have complete response and...
What is the current status of trial NCT05412082?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2022-10-05. Estimated completion is 2028-10-31.
What conditions does trial NCT05412082 study?
This clinical trial studies the following conditions: Locally Advanced Rectal Cancer.
What interventions are being tested in trial NCT05412082?
The interventions under investigation include: Capecitabine (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG), 5-fluorouracil (DRUG), Intensity-modulated radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT05412082?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05412082 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05412082's enrollment target sits among peer trials
25 1496th of 2000 higher than 481 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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