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SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer

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University of Miami

Status and phase

Enrolling
Phase 1

Conditions

Locally Advanced Rectal Cancer

Treatments

Drug: Leucovorin
Radiation: Accelerated Radiation Therapy
Drug: 5-fluorouracil
Drug: Oxaliplatin
Radiation: Intensity-modulated radiation therapy
Drug: Capecitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT05412082
20210172

Details and patient eligibility

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.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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 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).

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

25 participants in 2 patient groups

SMART TNT Plan I
Experimental group
Description:
Participants will initiate therapy with neoadjuvant chemotherapy of either six (6) 14-day cycles of 5-fluorouracil + leucovorin + oxaliplatin (FOLFOX) or four (4) 21-day cycles of capecitabine+oxaliplatin (CAPOX). Participants will then receive chemo-radiation therapy according to Plan I as follows: Plan I (5 weeks): * MRI-guided pelvic IMRT to the Planning Tumor Volume (PTV) at a dose of 50 Grays (gy) delivered in 25 fractions (fx) over 5 weeks. * Concurrent chemotherapy beginning on Day 1 of RT either: * 5-FU delivered 5 or 7 days per week. * Capecitabine (Xeloda) delivered 5 days per week. After completing Plan I, participants achieving complete Clinical Response (cCR) after completing Plan I chemo-radiation will forgo the Plan II boost and continue to follow-up. Participants not achieving cCR will begin Plan II, one week after completing Plan I.
Treatment:
Drug: Capecitabine
Radiation: Intensity-modulated radiation therapy
Drug: Oxaliplatin
Drug: 5-fluorouracil
Drug: Leucovorin
SMART TNT Plan II
Experimental group
Description:
Plan II boost RT (1 week): For participants not achieving cCR after chemo-radiation. Participants will receive MRI-guided accelerated radiation therapy (ART) boost to the primary tumor. Participants achieving a cCR will continue to follow-up. Participants still showing residual tumor will undergo standard of care treatment including surgery and adjuvant chemotherapy per institutional guidelines during follow-up.
Treatment:
Radiation: Accelerated Radiation Therapy

Trial contacts and locations

1

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Central trial contact

Zuzel Rodriguez

Data sourced from clinicaltrials.gov

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