SMART TNT for Locally Advanced Rectal Cancer

This study is looking at a new way to treat locally advanced rectal cancer (LARC). It combines chemotherapy (using 5-fluorouracil, Leucovorin, Oxaliplatin, and Capecitabine) with a higher dose of radiation therapy (Intensity-modulated radiation therapy, or IMRT). The goal is to see if this treatment can lead to a complete response, potentially allowing patients to avoid surgery. You might be able to join if you have newly diagnosed rectal adenocarcinoma, with the tumor within 18 cm from the anal verge, and meet certain tumor staging criteria (T3N0 or T1-4 N positive). The main thing the researchers are tracking is any side effects or toxicity from the treatment, for up to 30 months. The current status of this study is unclear, and it plans to enroll 25 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 25 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for the incidence of toxicity for up to 30 months after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05412082

SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Miami
~25 participants
Updated 2026-02-06 on ClinicalTrials.gov
What's tested:Intensity-modulated radiation therapy5-fluorouracilLeucovorinOxaliplatinCapecitabineAccelerated Radiation Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Toxicity Among Participants After Start Receiving MRI-g Pelvic ART
Measured over Up to 30 months
Locally Advanced Rectal Cancer
1 sites across 1 states
Florida1
  • Benjamin Spieler, MD · PRINCIPAL_INVESTIGATOR · University of Miami

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  • Incidence of Toxicity Among Participants After Start Receiving MRI-g Pelvic ARTUp to 30 months

    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.