Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction
- Conditions
- Metastatic Carcinoma
- Interventions
- Radiation: Stereotactic ablative body radiation therapy
- 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single-fraction SABR Stereotactic ablative body radiation therapy 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.
- Primary Outcome Measures
Name Time Method Number of SABR successfully delivered in one fraction through study completion, an average of 1 year Number of SABRs that meet the following criteria:
1. Successful completed for each lesion within 3 days of intended treatment
2. Successful completion of treatment to each lesion within 90 minutes from the patient entering the treatment room until treatment completion
3. Image guidance verification of treatment delivery within 5 mm of the planned deliveryNumber 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 within 90 days of completing SABR
2. No grade 5 toxicity is attributed to SABR
- Secondary Outcome Measures
Name Time Method Change in one-year local control baseline, up to 12 months after treatment 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.
Change in participant reported quality of life questionnaire baseline, up to 12 months after treatment 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.
Number of participants with one-year overall survival 12 months after treatment 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 baseline, during treatment, up to 12 months after treatment 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.
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