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

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ClinicalTrials.gov Identifier: NCT04939246
Recruitment Status : Not yet recruiting
First Posted : June 25, 2021
Last Update Posted : June 25, 2021
Sponsor:
Collaborator:
Viewray Inc.
Information provided by (Responsible Party):
Baptist Health South Florida

Brief Summary:
This is a 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.

Condition or disease Intervention/treatment Phase
Metastatic Carcinoma Radiation: Stereotactic ablative body radiation therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study of Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction for Inoperable Primary or Metastatic Carcinoma (SMART ONE)
Estimated Study Start Date : September 1, 2021
Estimated Primary Completion Date : April 28, 2023
Estimated Study Completion Date : April 28, 2024

Arm Intervention/treatment
Single-fraction SABR
Patients will receive SABR in a single-fraction regiment treatment with one single dose of radiation therapy per lesion. Patients may be treated for up to a total of ten lesions. Each lesion will be treated in one fraction.
Radiation: Stereotactic ablative body radiation therapy
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 Outcome Measures :
  1. Number of SABR successfully delivered in one fraction [ Time Frame: through study completion, an average of 1 year ]

    Number of SABRs that meet the following criteria:

    1. Successful completed for each lesion within 3 days of intended treatment
    2. Successful completion of treatment to each lesion within 90 minutes from the patient entering the treatment room until treatment completion
    3. 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:

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


Secondary Outcome Measures :
  1. Change in one-year local control [ Time Frame: baseline, up to 12 months after treatment ]
    Change in one-year local control will be assessed according to RECIST 1.1 criteria and will be estimated using the Kaplan-Meier method along with the corresponding 95% confidence interval from the time of study treatment.

  2. Number of participants with one-year overall survival [ Time Frame: 12 months after treatment ]
    Number 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. Proportion of participants with a change in acute and late toxicity results [ Time Frame: baseline, during treatment, up to 12 months after treatment ]
    Proportion of participants with a change in acute and late toxicity results who experience acute grade 3 or higher toxicity attributable to SABR will be determined along with the corresponding 95% confidence interval. 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, up to 12 months after treatment ]
    Patient-reported quality of life will be determined using the FACT-G survey instrument. Fact-G is a 27-item questionnaire that covers four HR-QOL sub-domains: physical, social, emotional, and function well being. Each question will be scored from a scale from 0 (not at all) to 4 (very much) using a manual scoring template in which some items are reverse.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. ≥18 years of age at the time of study enrollment
  2. 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
  3. Any lesion that would receive SABR is no larger than 5 cm in greatest dimension
  4. 1-10 total lesions that would receive SABR
  5. If multiple lesions are treated, they must be at least 3 cm apart
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  7. Life expectancy at least 6 months
  8. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.

Exclusion criteria

  1. Contraindication to having an MRI scan
  2. Central or ultracentral lung tumor defined as a lesion located within 2cm of the trachea and proximal bronchial tree for which patient is receiving SABR to a separate site that would receive SABR on this study.
  3. Cytotoxic chemotherapy or investigational agent within 2 weeks of stereotactic body radiation therapy (SBRT)
  4. Presence of uncontrolled brain metastases, spinal cord compression, or leptomeningeal carcinomatosis
  5. Any unresolved toxicity (Common Terminology Criteria for Adverse Events version 5.0 > grade 2) from previous anti-cancer therapy
  6. Any condition in the opinion of the investigator that would interfere with evaluation of study treatment or interpretation of patient safety or study results
  7. Prior radiation therapy that directly overlaps any radiation therapy given in this study
  8. Prior 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
  9. Female patients who are pregnant or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04939246


Contacts
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Contact: Michael Chuong, MD 786-596-2000 MichaelChu@baptisthealth.net

Locations
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United States, Florida
Miami Cancer Institute at Baptist Health South Florida
Miami, Florida, United States, 33176
Sponsors and Collaborators
Baptist Health South Florida
Viewray Inc.
Investigators
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Principal Investigator: Michael Chuong, MD Miami Cancer Institute (MCI) at Baptist Health, Inc.
Additional Information:
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Responsible Party: Baptist Health South Florida
ClinicalTrials.gov Identifier: NCT04939246    
Other Study ID Numbers: 2020-CHU-002
First Posted: June 25, 2021    Key Record Dates
Last Update Posted: June 25, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms