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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Carcinoma
• Intervention / Treatment: Radiation: Stereotactic ablative body radiation therapy

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Chuong, MD; Phone Number: 786-596-2000; Email: MichaelChu@baptisthealth.net
• Study Contact Backup: Name: Dilanis C Perche; Phone Number: (786)527-7606; Email: Dilanis.Perche@baptisthealth.net

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33176
      • Miami Cancer Institute at Baptist Health South Florida
  • Wisconsin
    • Madison, Wisconsin, United States, 53717
      • University of Wisconsin Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	through study completion, an average of 1 year
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	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, up to 12 months after 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.	12 months after 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.	baseline, during treatment, up to 12 months after treatment
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.	baseline, up to 12 months after treatment

Collaborators and Investigators

• Sponsor: Baptist Health South Florida
• Collaborators: Viewray Inc.
• Investigators: Principal Investigator: Michael Chuong, MD, Miami Cancer Institute (MCI) at Baptist Health, Inc.

Publications and helpful links

Helpful Links

• MCI - Website

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2021
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: June 10, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma
• Other Study ID Numbers: 2020-CHU-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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