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RECRUITINGPHASE1

SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer

Selective Treatment With Magnetic Resonance Image Guided Pelvic Adaptive Radiation Therapy Combined With Total Neoadjuvant ChemoTherapy for the Conservative Management of Locally Advanced Rectal Cancer

NCT05412082•University of Miami

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•9. Patient is assessed by a surgeon, medical oncologist and a radiation oncologist and deemed fit for Total Neoadjuvant ChemoTherapy (TNT) and surgery.

Exclusion Criteria

•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.
•9. 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
•10. Sensory or motor neuropathy ≥ grade 2.
+2 more criteria

Locations (1)

University of Miami

Miami, Florida, United States

Key Dates

Start Date

October 5, 2022

Primary Completion Date

October 31, 2026

Completion Date

October 31, 2028

Last Updated

February 6, 2026

Enrollment

ESTIMATED participants

Conditions

Locally Advanced Rectal Cancer

Interventions

Intensity-modulated radiation therapy

RADIATION

5-fluorouracil

DRUG

Leucovorin

DRUG

Oxaliplatin

DRUG

Capecitabine

DRUG

Accelerated Radiation Therapy

RADIATION

Irinotecan

DRUG

Contacts

Zuzel Rodriguez

CONTACT

305-243-0124 z.rodriguez1@med.miami.edu

Node-sparing Radiotherapy Combined with Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer

NCT06204094

Locally Advanced Rectal Cancer

View study

RECRUITINGPHASE2

Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence

NCT05054959

Locally Advanced Rectal Cancer

View study

ACTIVE_NOT_RECRUITINGNA

A Pospective, Single-arm, Multicenter Clinical Trial Evaluating Preoperative Neoadjuvant mFOLFOX6 Chemotherapy in Combination With PD1 Monoclonal Antibody in MSS/pMMR Locally Advanced Rectal Cancer

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer

Inclusion Criteria

Exclusion Criteria

Node-sparing Radiotherapy Combined with Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer

Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence

A Pospective, Single-arm, Multicenter Clinical Trial Evaluating Preoperative Neoadjuvant mFOLFOX6 Chemotherapy in Combination With PD1 Monoclonal Antibody in MSS/pMMR Locally Advanced Rectal Cancer

Intraoperative Electron Radiotherapy in Rectal Cancer - A Feasibility Trial

Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer

GEMCAD-REVEAL STUDY - Circulating Tumor DNA as a Predictor of Relapse in Patients With Locally Advanced Rectal Cancer.