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

Not Applicable

Completed

Conditions: Metastatic Carcinoma

Registration Number: NCT04939246

Lead Sponsor: Baptist Health South Florida

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants With SABR Successfully Delivered in One Fraction	through study completion, an average of 1 year	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
Number of Patients Demonstrating Tolerability	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 is attributable to SABR within 90 days of completing SABR 2. No grade 5 toxicity is attributed to SABR

Secondary Outcome Measures

Name	Time	Method
One-year Local Control	12 months	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.
Percent of Participants With One-year Overall Survival	12 months	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.
Number of Participants With Acute and Late Toxicity Results	12 months	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.
Change in Participant Reported Quality of Life Questionnaire	baseline, 3, 6, 9, and 12 months after treatment	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).

Trial Locations

Locations (2): Miami Cancer Institute at Baptist Health South Florida
🇺🇸
Miami, Florida, United States
University of Wisconsin Hospital and Clinics
🇺🇸
Madison, Wisconsin, United States
Miami Cancer Institute at Baptist Health South Florida
🇺🇸Miami, Florida, United States