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RECRUITING Phase 1

SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer

NCT05412082 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 25 participants
Start Date 2022-10-05
Est. Completion 2028-10-31
Phase Phase 1

Sponsor

University of Miami

667 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05412082

The ClinicalTrials.gov registry entry for NCT05412082 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 667 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05412082 reports 1 study location spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05412082?

This trial is sponsored by University of Miami, which has 667 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial