Clinical trial NCT05412082: SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Locally Advanced Rectal Cancer
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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 criteria: 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.
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).

Primary outcomes:
measure: Incidence of Toxicity Among Participants After Start Receiving MRI-g Pelvic ART
timeFrame: Up to 30 months
Secondary outcomes:
measure: Incidence of Acute and Long-Term Toxicity After Start of Study Therapy
timeFrame: Up to 30 months
measure: Percentage of Participants with Documented Local Control
timeFrame: Up to 2 years
measure: Percentage of Participants with Documented Distant Metastasis
timeFrame: Up to 2 years
measure: Disease-free Survival (DFS) rate
timeFrame: Up to 2 years
measure: Overall Survival (OS)
timeFrame: Up to 2 years
measure: Percentage of Real Negatives
timeFrame: Up to 6 months
measure: Health-related Quality of Life (HRQOL) Scores: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Up to 30 months
measure: Health-related Quality of Life (HRQOL) Scores: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Up to 30 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Benjamin Spieler, MD
role: PRINCIPAL_INVESTIGATOR
References: