RecruitingLocally Advanced Rectal Cancer

SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

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About this study

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.

Sponsor: University of Miami

You may qualify if…

✓ 1. Patients with newly diagnosed, biopsy proven, rectal adenocarcinoma.
✓ 2. Primary tumor located ≤18 cm from margin verge.
✓ 3. Primary tumor either a T3N0 or T1-4 N positive (as defined per pelvic MRI; nodes ≤ 15 mm).
✓ 4. ≥ 18 years of age.
✓ 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
✓ 6. Serum liver function tests values within the range of 1.5 x Upper Limit of Normal (within 6 weeks of enrollment).
✓ 7. Negative pregnancy test for women of child-bearing potential (within 4 weeks of enrollment).
✓ 8. Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if…

✕ 1. Metastatic disease on initial work up (Chest and abdomen contrast enhanced CT scan).
✕ 2. Synchronous cancer found on colonoscopy.
✕ 3. Previous history of pelvic radiotherapy.
✕ 4. History of concurrent, active malignancy other than non-metastatic skin cancer within the last 2 years.
✕ 5. 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.
✕ 6. Psychiatric illness/social situations that would limit compliance with study requirements.
✕ 7. Active (acute or chronic) or uncontrolled severe infections requiring intravenous antibiotics or active tuberculosis (TB).
✕ 8. 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.

Where it's recruiting

Florida

Miami

Source: ClinicalTrials.gov · NCT05412082 · last updated 2026-02-06