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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Miami Cancer Institute at Baptist Health South Florida
Miami, Florida, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Number of Participants With SABR Successfully Delivered in One Fraction
To be considered successful, SABR treatment must meet the following criteria: 1. Successful completion of treatment to each lesion within 3 days of intended treatment date 2. 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 3. Image guidance verification of treatment delivery within 5 mm of the planned delivery
Time frame: through study completion, an average of 1 year
Number of Patients Demonstrating Tolerability
Number of patients that meet the following criteria: 1. No greater than 4 of 30 patients experience grade 3 or higher acute toxicity is attributable to SABR within 90 days of completing SABR 2. No grade 5 toxicity is attributed to SABR
Time frame: through study completion, an average of 1 year
One-year Local Control
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.
Time frame: 12 months
Percent of Participants With One-year Overall Survival
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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.
Time frame: 12 months
Number of Participants With Acute and Late Toxicity Results
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.
Time frame: 12 months
Change in Participant Reported Quality of Life Questionnaire
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).
Time frame: baseline, 3, 6, 9, and 12 months after treatment