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

Primary Purpose

Metastatic Carcinoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stereotactic ablative body radiation therapy
Sponsored by
Baptist Health South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  1. Subject must be ≥18 years of age at the time of study enrollment
  2. 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
  3. Any lesion that would receive SABR under this study protocol 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) 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.
  9. 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

  1. Subject has contraindication to having an MRI scan
  2. 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
  3. Subject has received cytotoxic chemotherapy or investigational agent within 2 weeks of SBRT
  4. Subject has uncontrolled brain metastases, spinal cord compression, or leptomeningeal carcinomatosis
  5. Subject has any unresolved toxicity (Common Terminology Criteria for Adverse Events version 5.0 > grade 2) from previous anti-cancer therapy
  6. 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
  7. Subject has received prior radiation therapy that directly overlaps any radiation therapy given in this study
  8. 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
  9. Female subject who are pregnant or breastfeeding
  10. 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.

Sites / Locations

  • Miami Cancer Institute at Baptist Health South Florida
  • University of Wisconsin Hospital and Clinics

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single-fraction SABR

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of SABR successfully delivered in one fraction
Number of SABRs that meet the following criteria: Successful completed for each lesion within 3 days of intended treatment Successful completion of treatment to each lesion within 90 minutes from the patient entering the treatment room until treatment completion Image guidance verification of treatment delivery within 5 mm of the planned delivery
Number of patients demonstrating tolerability
Number of patients that meet the following criteria: No greater than 4 of 30 patients experience grade 3 or higher acute toxicity within 90 days of completing SABR No grade 5 toxicity is attributed to SABR

Secondary Outcome Measures

Change in one-year local control
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.
Number of participants with one-year overall survival
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.
Proportion of participants with a change in acute and late toxicity results
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.
Change in participant reported quality of life questionnaire
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.

Full Information

First Posted
June 10, 2021
Last Updated
August 7, 2023
Sponsor
Baptist Health South Florida
Collaborators
Viewray Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04939246
Brief Title
Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction
Acronym
SMART ONE
Official Title
A Feasibility Study of Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction for Inoperable Primary or Metastatic Carcinoma (SMART ONE)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 18, 2021 (Actual)
Primary Completion Date
April 28, 2024 (Anticipated)
Study Completion Date
April 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baptist Health South Florida
Collaborators
Viewray Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single-fraction SABR
Arm Type
Other
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic ablative body radiation therapy
Intervention Description
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 Measure Information:
Title
Number of SABR successfully delivered in one fraction
Description
Number of SABRs that meet the following criteria: Successful completed for each lesion within 3 days of intended treatment Successful completion of treatment to each lesion within 90 minutes from the patient entering the treatment room until treatment completion Image guidance verification of treatment delivery within 5 mm of the planned delivery
Time Frame
through study completion, an average of 1 year
Title
Number of patients demonstrating tolerability
Description
Number of patients that meet the following criteria: No greater than 4 of 30 patients experience grade 3 or higher acute toxicity within 90 days of completing SABR No grade 5 toxicity is attributed to SABR
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Change in one-year local control
Description
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.
Time Frame
baseline, up to 12 months after treatment
Title
Number of participants with one-year overall survival
Description
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.
Time Frame
12 months after treatment
Title
Proportion of participants with a change in acute and late toxicity results
Description
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.
Time Frame
baseline, during treatment, up to 12 months after treatment
Title
Change in participant reported quality of life questionnaire
Description
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.
Time Frame
baseline, up to 12 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Chuong, MD
Organizational Affiliation
Miami Cancer Institute (MCI) at Baptist Health, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami Cancer Institute at Baptist Health South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53717
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://baptisthealth.net/cancer-care/home
Description
MCI - Website

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

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