Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05412082

SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer

Led by University of Miami · Updated on 2026-02-06

25

Participants Needed

1

Research Sites

316 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with newly diagnosed, biopsy proven, rectal adenocarcinoma.
  • Primary tumor located 418 cm from margin verge.
  • Primary tumor either a T3N0 or T1-4 N positive (as defined per pelvic MRI; nodes 415 mm).
  • 418 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Serum liver function tests values within the range of 1.5 x Upper Limit of Normal (within 6 weeks of enrollment).
  • Negative pregnancy test for women of child-bearing potential (within 4 weeks of enrollment).
  • Ability to understand and the willingness to sign a written informed consent document.
  • Patient is assessed by a surgeon, medical oncologist and a radiation oncologist and deemed fit for Total Neoadjuvant ChemoTherapy (TNT) and surgery.
Not Eligible

You will not qualify if you...

  • Metastatic disease on initial work up (Chest and abdomen contrast enhanced CT scan).
  • Synchronous cancer found on colonoscopy.
  • Previous history of pelvic radiotherapy.
  • History of concurrent, active malignancy other than non-metastatic skin cancer within the last 2 years.
  • Symptomatic congestive heart failure of New York Heart Association Class III or IV, unstable angina pectoris or uncontrolled severe cardiac arrhythmia, myocardial infarction within the last 6 months.
  • Psychiatric illness/social situations that would limit compliance with study requirements.
  • Active (acute or chronic) or uncontrolled severe infections requiring intravenous antibiotics or active tuberculosis (TB).
  • Patients with poorly controlled acquired immune deficiency syndrome (AIDS) who are not deemed candidates for FOLFOX, mFOLFIRINOX or CAPOX chemotherapy.
  • Active connective tissue disorders, such as lupus or scleroderma, that, in the opinion of the treating physician may put the patient at high risk for radiation toxicity.
  • Sensory or motor neuropathy 4 grade 2.
  • Women who are breast feeding.
  • Exclusions due to MRI use in study: ferromagnetic metal in body/eye, pacemaker, defibrillator, other mechanical device, or extreme claustrophobia (medication with anti-anxiety agents, such as Ativan, may be attempted).

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

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Research Team

Z

Zuzel Rodriguez

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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