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Radiation Therapy
Focused Radiation Therapy for Cancer (SMART ONE Trial)
N/A
Waitlist Available
Led By Michael Chuong, MD
Research Sponsored by Baptist Health South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
1-10 total lesions that would receive SABR
If multiple lesions are treated, they must be at least 3 cm apart
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
SMART ONE Trial Summary
This trial is testing a new, more focused type of radiation treatment for cancer in different parts of the body.
Who is the study for?
This trial is for adults with certain types of cancer (lung, liver, adrenal gland, pancreas, kidney, or abdominal/pelvic lymph nodes) that can be treated with focused radiation. Participants must have started any hormonal or immunotherapy at least 4 weeks prior to the study and agree to use contraception. They should not have had chemotherapy within 2 weeks before the study or have unresolved side effects from previous treatments.Check my eligibility
What is being tested?
The trial tests a single-session Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) on tumors no larger than 5 cm and spaced at least 3 cm apart if multiple are present. It aims to deliver intense radiation doses directly to tumors while sparing surrounding healthy tissue.See study design
What are the potential side effects?
Potential side effects include damage to nearby organs due to high-intensity radiation exposure which could lead to symptoms depending on the organ affected (e.g., coughing or difficulty breathing for lung involvement), fatigue, skin reactions in the treated area, and nausea.
SMART ONE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have between 1 and 10 tumors eligible for targeted radiation therapy.
Select...
My treatment targets multiple areas, each at least 3 cm apart.
Select...
My cancer, confirmed by biopsy, affects my lung, liver, adrenal gland, pancreas, kidney, or abdominal/pelvic lymph node and is eligible for SABR treatment.
Select...
I am 18 years old or older.
Select...
My cancer lesion is no larger than 5 cm.
Select...
I can take care of myself and am up and about more than half of my waking hours.
SMART ONE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of SABR successfully delivered in one fraction
Number of patients demonstrating tolerability
Secondary outcome measures
Change in one-year local control
Change in participant reported quality of life questionnaire
Number of participants with one-year overall survival
+1 moreSMART ONE Trial Design
1Treatment groups
Experimental Treatment
Group I: Single-fraction SABRExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Baptist Health South FloridaLead Sponsor
48 Previous Clinical Trials
7,801 Total Patients Enrolled
Viewray Inc.Industry Sponsor
12 Previous Clinical Trials
1,059 Total Patients Enrolled
Michael Chuong, MDPrincipal InvestigatorMiami Cancer Institute (MCI) at Baptist Health, Inc.
1 Previous Clinical Trials
133 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously received radiation in the same area that this study targets.I have between 1 and 10 tumors eligible for targeted radiation therapy.I have untreated brain metastases or spinal issues due to cancer.I am not pregnant or breastfeeding.I've had radiation therapy that might cause significant harm to healthy tissues, as assessed by my doctor.I don't have severe side effects from past cancer treatments.I have had chemotherapy or tried a new treatment within 2 weeks before my targeted radiation therapy.My treatment targets multiple areas, each at least 3 cm apart.My cancer, confirmed by biopsy, affects my lung, liver, adrenal gland, pancreas, kidney, or abdominal/pelvic lymph node and is eligible for SABR treatment.I started hormonal therapy or immunotherapy at least 4 weeks before SABR.My lung tumor is very close to my trachea or main airways.I am 18 years old or older.I have not taken, nor plan to take, VEGF inhibitors like bevacizumab around the study period.My cancer lesion is no larger than 5 cm.I can take care of myself and am up and about more than half of my waking hours.I agree to use birth control or practice abstinence during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Single-fraction SABR
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment process for this research endeavor still open?
"Data from clinicaltrials.gov shows that this research endeavour is currently attempting to enrol patients, with the original post dated June 18th 2021 and last edited April 15th 2022."
Answered by AI
How many participants are currently taking part in this medical experiment?
"Affirmative. According to the clinicaltrials.gov website, this medical research is presently recruiting study participants; it was published on June 18th 2021 and last amended on April 15th 2022. The experiment requires 30 patients enrolled across 2 sites."
Answered by AI
What are the primary goals of this medical experiment?
"According to the trial sponsor Viewray Inc., the main objective being evaluated over a course of 1 year is how well patients tolerate treatment. Additionally, secondary outcomes such as one-year local control according to RECIST 1.1 criteria and Kaplan-Meier method with 95% confidence intervals, number of participants with one-year overall survival estimated using Kaplan Meier method again with corresponding 95% confidence interval from time of study treatment, and patient reported quality of life determined by FACT-G survey instrument will be assessed. The latter evaluates 4 HRQOL domains: physical, social, emotional and functional wellbeing through 27 questions scoring between 0 (not"
Answered by AI
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