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SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer

ConditionLocally Advanced Rectal Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Patients with newly diagnosed, biopsy proven, rectal adenocarcinoma.

Primary tumor located ≤18 cm from margin verge.

Primary tumor either a T3N0 or T1-4 N positive (as defined per pelvic MRI; nodes ≤ 15 mm).

≥ 18 years of age.

Disqualifiers

Metastatic disease on initial work up (Chest and abdomen contrast enhanced CT scan).

Synchronous cancer found on colonoscopy.

Previous history of pelvic radiotherapy.

History of concurrent, active malignancy other than non-metastatic skin cancer within the last 2 years.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Intensity-modulated radiation therapy

    Radiation

    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.

  • 5-fluorouracil

    Drug

    5-FU dose of 400 mg/m2 will be administered intravenously (IV) over 5-15 minutes beginning on Day 1; then a dose of 2400 mg/m2 via continual infusion (CI) over 4446-478 hours total dose during Days 1 and 2 of every 14-day cycle, for 4 to 6 cycles. During SMART TNT Plan I, 5-FU dose of 225 mg/m2 per day will be administered via CI on Day 1 radiation therapy, delivered either 5 or 7 days per week.

  • Leucovorin

    Drug

    Leucovorin dose of 400 mg/m2 bolus will be administered intravenously (IV) on Day 1 of each 14-day cycle for 4 to 6 cycles, prior to SMART TNT Plan I radiation therapy.

  • Oxaliplatin

    Drug

    Oxaliplatin dose of 85 mg/m2 will be administered intravenously (IV) on Day 1 of each 14-day cycle for 4 - 6 cycles.

  • Capecitabine

    Drug

    Capecitabine will be administered orally at a dose of 825 mg/m2 via tablet twice per day (BID) on Day 1, 5 days per week.

  • Accelerated Radiation Therapy

    Radiation

    MRI-guided Pelvic accelerated radiation therapy (ART) given over one week at one of the following dose levels : * Dose level -1: 10 Gy delivered in 4 fractions * Dose level 0: 12 Gy delivered in 4 fractions * Dose level 1: 14 Gy delivered in 4 fractions * Dose level 2: 16 Gy in delivered 4 fractions

  • Irinotecan

    Drug

    Irinotecan dose of 180 mg/m2 will be administered intravenously (IV) on Day 1 of each 14-day cycle for 4 to 6 cycles, prior to SMART TNT Plan I radiation therapy.

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: SMART TNT Plan IExperimental treatment 6 interventions
Group B: SMART TNT Plan IIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Toxicity Among Participants After Start Receiving MRI-g Pelvic ART

Reported as the incidence of toxicity (adverse events and serious adverse events) in study participants after start of MRI-g Pelvic ART. Toxicity in study participants will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.

Time frame
Up to 30 months

Secondary outcomes

1

Incidence of Acute and Long-Term Toxicity After Start of Study Therapy

Reported as the incidence of grade 3 or higher acute and long-term toxicity by organ in study participants after start of study therapy. These toxicities will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.

Time frame
Up to 30 months
2

Percentage of Participants with Documented Local Control

Local control is defined as the stopping of cancer growth at the original primary site. The percentage of participants with documented local control after study therapy will be reported.

Time frame
Up to 2 years
3

Percentage of Participants with Documented Distant Metastasis

Distant metastasis is defined as cancer that has spread form the original (primary) tumor to distant organs and distant lymph nodes. The percentage of participants with documented distant metastasis after study therapy will be reported.

Time frame
Up to 2 years
4

Disease-free Survival (DFS) rate

Disease-free survival is defined as the elapsed time after treatment that a person with disease lives without known disease recurrence. DFS rate will be reported as the percentage of participants without disease recurrence after start of treatment.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Source ClinicalTrials.gov
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