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Completed

NCT Number: NCT04939246

Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction

This is a multi-site single arm feasibility study of single-fraction Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) for primary or metastatic carcinoma involving the lung, liver, adrenal gland, abdominal/pelvic lymph node, pancreas, and/or kidney. Stereotactic ablative body radiation therapy (SABR) is a highly-focused radiation treatment that gives an intense dose of radiation concentrated on a tumor, while limiting the dose to the surrounding organs.

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Key information

Conditions

Metastatic Carcinoma Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Miami Cancer Institute at Baptist Health South Florida, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject must be ≥18 years of age at the time of study enrollment
  • Subject must have Biopsy-confirmed primary or metastatic carcinoma with involvement of the lung, liver, adrenal gland, pancreas, kidney, and/or abdominal/pelvic lymph node that would receive SABR
  • Any lesion that would receive SABR under this study protocol is no larger than 5 cm in greatest dimension
  • 1-10 total lesions that would receive SABR
  • If multiple lesions are treated, they must be at least 3 cm apart
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Life expectancy at least 6 months
  • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Abstinence is acceptable if it's the patient preferred method. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
  • Patients receiving hormonal therapy or immunotherapy such as immune checkpoint inhibitor that had begun at least 4 weeks prior to SABR will be allowed.

Exclusion criteria

  • Subject has contraindication to having an MRI scan
  • Subject has central or ultra-central lung tumor that would receive SABR on this study, defined as a lesion located within 2 cm of the trachea and proximal bronchial tree
  • Subject has received cytotoxic chemotherapy or investigational agent within 2 weeks of SBRT
  • Subject has uncontrolled brain metastases, spinal cord compression, or leptomeningeal carcinomatosis
  • Subject has any unresolved toxicity (Common Terminology Criteria for Adverse Events version 5.0 > grade 2) from previous anti-cancer therapy
  • Subject has any condition in the opinion of the investigator that would interfere with evaluation of study treatment or interpretation of patient safety or study results
  • Subject has received prior radiation therapy that directly overlaps any radiation therapy given in this study
  • Subject has received radiation therapy that could lead to an unacceptably high risk of clinically significant normal tissue injury due to high cumulative normal tissue dose as determined by the investigator
  • Female subject who are pregnant or breastfeeding
  • Subject who has received vascular endothelial growth factor (VEGF) inhibitor such as bevacizumab within 4 weeks prior to study therapy or planned to receive it within 4 weeks after study therapy.

Treatment and study plan

Stereotactic ablative body radiation therapy

Radiation

Single-fraction of stereotactic ablative body radiation (SABR) therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian Linac). The prescription dose is dependent on the anatomic location of the lesion and based on previously published safety data.

Primary outcomes

  1. Number of Participants With SABR Successfully Delivered in One Fraction

    Time frame: through study completion, an average of 1 year

    To be considered successful, SABR treatment must meet the following criteria:

    • Successful completion of treatment to each lesion within 3 days of intended treatment date
    • Successful completion of treatment to each lesion within 90 minutes from the patient entering the treatment room until treatment completion for at least 80% of treated lesions
    • Image guidance verification of treatment delivery within 5 mm of the planned delivery

  2. Number of Patients Demonstrating Tolerability

    Time frame: through study completion, an average of 1 year

    Number of patients that meet the following criteria:

    • No greater than 4 of 30 patients experience grade 3 or higher acute toxicity is attributable to SABR within 90 days of completing SABR
    • No grade 5 toxicity is attributed to SABR

Secondary outcomes

  1. One-year Local Control

    Time frame: 12 months

    Assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and estimated with Kaplan-Meier and corresponding 95% confidence interval from the time of study treatment.

    Target lesion:

    • Complete response (CR): Disappearance of all target lesions
    • Partial response (PR): >30% decrease in the sum of the diameters of target lesions
    • Stable disease (SD): Target lesion has neither sufficient decrease to qualify as a PR or sufficient increase to qualify as progressive disease (PD)
    • PD: At least a 20% increase in the sum of the diameters of target lesions an absolute increase of at least 5 mm

    Non-target lesion:

    • CR: Disappearance of all non-target lesions
    • SD: Persistence of ≥1 non-target lesions
    • PD: Appearance of ≥1 new lesions or unequivocal progression of existing non-target lesions

    Overall:

    • CR: Target CR+non-target CR
    • PR: Target CR/PR+non-target non-PD
    • SD: Target SD+non-target non-PD
    • PD: Anything else

    Local control=CR+PR+SD using overall response.

  2. Percent of Participants With One-year Overall Survival

    Time frame: 12 months

    Percent of participants with one-year overall survival will be estimated using the Kaplan-Meier method along with the corresponding 95% confidence interval from the time of study treatment.

  3. Number of Participants With Acute and Late Toxicity Results

    Time frame: 12 months

    Number of participants with acute and late toxicities defined as grade 3 or higher toxicity attributable to SABR will be determined. For patients receiving SABR to multiple lesions, acute toxicity will be determined from the date of the initiation of SABR.

  4. Change in Participant Reported Quality of Life Questionnaire

    Time frame: baseline, 3, 6, 9, and 12 months after treatment

    Patient-reported quality of life will be determined using the Functional Assessment of Cancer Therapy - General (FACT-G) survey instrument. FACT-G is a 27-item questionnaire that covers four sub-domains: physical (7 items), social (7 items), emotional, (6 items), and functional (7 items) well-being. Each question is scored from a scale from 0 (not at all) to 4 (very much) using a manual scoring template in which some items are reversed. After reversal of specified items, the sub-domain scores are totaled, then multiplied by the number of items in the sub-domain, and then divided by the number of items the participant answered. The scores for each sub-domain are 0 (worst well-being) to 24 (best emotional well-being) or 28 (best physical, social, or functional well-being). The total scores can range from 0 (worst overall well-being) to 108 (best overall well-being).

Sponsors and collaborators

Lead sponsor

Baptist Health South Florida

Other

Collaborators

  • Viewray Inc.

Registry information

Official study title

A Feasibility Study of Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction for Inoperable Primary or Metastatic Carcinoma (SMART ONE)

Acronym: SMART ONE

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 25, 2021
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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