Description:
This is a 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.
Title
- Brief Title: Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction
- Official Title: A Feasibility Study of Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction for Inoperable Primary or Metastatic Carcinoma (SMART ONE)
Clinical Trial IDs
- ORG STUDY ID:
2020-CHU-002
- NCT ID:
NCT04939246
Conditions
Purpose
This is a 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.
Trial Arms
Name | Type | Description | Interventions |
---|
Single-fraction SABR | Other | 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. | |
Eligibility Criteria
Inclusion Criteria
1. ≥18 years of age at the time of study enrollment
2. Biopsy-confirmed primary or metastatic carcinoma with involvement of the lung, liver,
adrenal gland, pancreas, kidney, and/or abdominal/pelvic lymph node that would receive
SABR
3. Any lesion that would receive SABR is no larger than 5 cm in greatest dimension
4. 1-10 total lesions that would receive SABR
5. If multiple lesions are treated, they must be at least 3 cm apart
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
7. Life expectancy at least 6 months
8. Women of childbearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control, abstinence) prior to study entry and for
the duration of study participation. Should a woman become pregnant or suspect she is
pregnant while participating in this study, she must inform her treating physician
immediately.
Exclusion criteria
1. Contraindication to having an MRI scan
2. Central or ultracentral lung tumor defined as a lesion located within 2cm of the
trachea and proximal bronchial tree for which patient is receiving SABR to a separate
site that would receive SABR on this study.
3. Cytotoxic chemotherapy or investigational agent within 2 weeks of stereotactic body
radiation therapy (SBRT)
4. Presence of uncontrolled brain metastases, spinal cord compression, or leptomeningeal
carcinomatosis
5. Any unresolved toxicity (Common Terminology Criteria for Adverse Events version 5.0 >
grade 2) from previous anti-cancer therapy
6. Any condition in the opinion of the investigator that would interfere with evaluation
of study treatment or interpretation of patient safety or study results
7. Prior radiation therapy that directly overlaps any radiation therapy given in this
study
8. Prior radiation therapy that could lead to an unacceptably high risk of clinically
significant normal tissue injury due to high cumulative normal tissue dose as
determined by the investigator
9. Female patients who are pregnant or breastfeeding
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of SABR successfully delivered in one fraction |
Time Frame: | through study completion, an average of 1 year |
Safety Issue: | |
Description: | 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 |
Secondary Outcome Measures
Measure: | Change in one-year local control |
Time Frame: | baseline, up to 12 months after treatment |
Safety Issue: | |
Description: | 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. |
Measure: | Number of participants with one-year overall survival |
Time Frame: | 12 months after treatment |
Safety Issue: | |
Description: | 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. |
Measure: | Proportion of participants with a change in acute and late toxicity results |
Time Frame: | baseline, during treatment, up to 12 months after treatment |
Safety Issue: | |
Description: | 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. |
Measure: | Change in participant reported quality of life questionnaire |
Time Frame: | baseline, up to 12 months after treatment |
Safety Issue: | |
Description: | 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. |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | Baptist Health South Florida |
Last Updated
June 25, 2021