Clinical trial NCT04939246: Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction
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
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Carcinoma
Lead sponsor: Baptist Health South Florida
Sponsor class: OTHER
Collaborators: name: Viewray Inc.
First posted: 2021-06-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of SABR successfully delivered in one fraction
timeFrame: through study completion, an average of 1 year
measure: Number of patients demonstrating tolerability
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Change in one-year local control
timeFrame: baseline, up to 12 months after treatment
measure: Number of participants with one-year overall survival
timeFrame: 12 months after treatment
measure: Proportion of participants with a change in acute and late toxicity results
timeFrame: baseline, during treatment, up to 12 months after treatment
measure: Change in participant reported quality of life questionnaire
timeFrame: baseline, up to 12 months after treatment
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Cancer Institute at Baptist Health South Florida
state: Florida
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: Miami Cancer Institute (MCI) at Baptist Health, Inc.
name: Michael Chuong, MD
role: PRINCIPAL_INVESTIGATOR
References: