RECRUITING

SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-10-05

Study Completion:2027-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05412082

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	1. Metastatic disease on initial work up (Chest and abdomen contrast enhanced CT scan). 2. Synchronous lesion found on colonoscopy. 3. Previous history of pelvic radiotherapy. 4. History of concurrent, active malignancy, other than non metastatic skin cancer within the last 5 years. 5. Symptomatic congestive heart failure of New York Heart Association Class III or IV, unstable angina pectoris or serious uncontrolled 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. Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition or known HIV seropositivity; note, however, HIV testing is not required for entry into this protocol. The need to exclude patients with HIV/AIDS from this protocol is based on the fact that the treatments involved in this protocol may be significantly immunosuppressive. 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. 11. Women who are breast feeding. 12. 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).

Inclusion Criteria

Exclusion 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.

1. Metastatic disease on initial work up (Chest and abdomen contrast enhanced CT scan).
2. Synchronous lesion found on colonoscopy.
3. Previous history of pelvic radiotherapy.
4. History of concurrent, active malignancy, other than non metastatic skin cancer within the last 5 years.
5. Symptomatic congestive heart failure of New York Heart Association Class III or IV, unstable angina pectoris or serious uncontrolled 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. Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition or known HIV seropositivity; note, however, HIV testing is not required for entry into this protocol. The need to exclude patients with HIV/AIDS from this protocol is based on the fact that the treatments involved in this protocol may be significantly immunosuppressive.
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.
11. Women who are breast feeding.
12. 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).

Contacts and Locations

Study Contact

Zuzel Rodriguez

CONTACT

305-243-0124

z.rodriguez1@med.miami.edu

Principal Investigator

Lorraine Portelance, MD

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

University of Miami

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: University of Miami

Lorraine Portelance, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-05

Study Completion Date2027-10

Study Record Updates

Study Start Date2022-10-05

Study Completion Date2027-10

Terms related to this study

Additional Relevant MeSH Terms

Locally Advanced Rectal Cancer