Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction (SMART ONE)
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|ClinicalTrials.gov Identifier: NCT04939246|
Recruitment Status : Not yet recruiting
First Posted : June 25, 2021
Last Update Posted : June 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Carcinoma||Radiation: Stereotactic ablative body radiation therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Study of Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction for Inoperable Primary or Metastatic Carcinoma (SMART ONE)|
|Estimated Study Start Date :||September 1, 2021|
|Estimated Primary Completion Date :||April 28, 2023|
|Estimated Study Completion Date :||April 28, 2024|
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.
- Number of SABR successfully delivered in one fraction [ Time Frame: through study completion, an average of 1 year ]
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
- Number of patients demonstrating tolerability [ Time Frame: through study completion, an average of 1 year ]
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
- Change in one-year local control [ Time Frame: 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.
- Number of participants with one-year overall survival [ Time Frame: 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 [ Time Frame: 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.
- Change in participant reported quality of life questionnaire [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04939246
|Contact: Michael Chuong, MD||786-596-2000||MichaelChu@baptisthealth.net|
|United States, Florida|
|Miami Cancer Institute at Baptist Health South Florida|
|Miami, Florida, United States, 33176|
|Principal Investigator:||Michael Chuong, MD||Miami Cancer Institute (MCI) at Baptist Health, Inc.|