Metastatic Malignant Solid Neoplasm
Conditions
Brief summary
This clinical trial studies the side effects of magnetic resonance (MR)-guided stereotactic body radiation therapy (SBRT) and to see how well it works in treating patients with solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body. The total dose of radiation is divided into smaller doses given over 1-5 days. This type of radiation therapy helps spare normal tissue. During MR-guided SBRT, MR imaging is used to define and localize the area to be treated and provide more accurate delivery. This allows the treatment to be given over one day. MR-guided SBRT may be safe, tolerable, and/or effective in treating patients with metastatic solid tumors. Tumors in the central nervous system will not be treated on this study.
Detailed description
PRIMARY OBJECTIVE: I. To evaluate the incidence of acute grade ≥ 3 adverse events that are possibly, probably, or definitely related to single-fraction adaptive MR-guided SBRT. SECONDARY OBJECTIVES: I. To estimate local control (LC), progression-free survival (PFS) and overall survival (OS). II. To characterize late grade ≥ 3 toxicity rates per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. III. To assess patient-reported health-related quality of life (HRQOL) using Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) at baseline, end of treatment, 3 months post-treatment, and 1 year post-treatment. IV. To measure total in-room time, defined as the duration from patient entry to exit at the treatment console. OUTLINE: Patients undergo MR-guided SBRT over one treatment fraction on study. Patients also undergo magnetic resonance imaging (MRI) and computed tomography (CT) on study and CT or PET/CT throughout the study. After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months.
Interventions
PROCEDUREComputed Tomography
Undergo CT and/or PET/CT
PROCEDUREMagnetic Resonance Imaging
Undergo MRI
Undergo MR-guided SBRT
PROCEDUREPositron Emission Tomography
Undergo PET/CT
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Jonsson Comprehensive Cancer Center
Viewray Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) 0-2 * Histologically confirmed metastatic solid tumor (any primary site) * 1-3 metastases ≤ 5 cm each located outside the brain and spine * Lesions treatable at 25-30 Gy × 1 fraction with MR guidance * No overlapping prior radiation * Absolute neutrophil count (ANC) \> 1.5 cell/mm\^3 * Hemoglobin (Hgb) \> 8.0 gm/dL * Platelet (PLT) \> 150,000/mm\^3 * Total bilirubin \< or equal to 1.5 x upper limit of normal * Aspartate aminotransferase (AST) \< or equal to three times upper limit of normal * Alanine aminotransferase (ALT) \< or equal to three times upper limit of normal * Informed consent obtained
Exclusion criteria
* Uncontrolled infection or major comorbidity * Pregnant or breastfeeding * MRI contraindication * Life expectancy \< 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute toxicity rate | Up to 3 months post-radiation therapy | Defined as the percentage of patients who experience acute grade ≥ 3 adverse events relating to single-fraction adaptive magnetic resonance-guided stereotactic body radiation therapy. Will be calculated, along with the corresponding 95% Clopper-Pearson exact confidence interval. Assessed per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to local failure (Local control) | From end of study treatment to the presence of local or locoregional disease progression within the irradiated field, assessed up to 12 months | As assessed by imaging and clinical evaluation, according to Response Evaluation Criteria in Solid Tumors version 1.1. Will be estimated via Kaplan-Meier (KM) analysis. The median survival along with 95% confidence interval will also be reported. |
| Progression-free survival | From end of study treatment to the first documented evidence of disease progression or death from any cause, whichever occurs first, assessed up to 12 months | Will be estimated via KM analysis. The median survival along with 95% confidence interval will also be reported. |
| Overall survival | From end of study treatment to death from any cause, assessed up to 12 months | Will be estimated via KM analysis. The median survival along with 95% confidence interval will also be reported. |
| Incidence of late grade ≥ 3 toxicities | From 3 months post-radiation therapy up to 12 months post-radiation therapy | Assessed per CTCAE v5.0 for entire and sub-cohort, stratified by anatomic treatment site. Will be characterized via descriptive statistics. |
| PROMIS-29 patient-reported health-related quality-of-life (HRQOL) | Peritreatment/Periprocedural, 3 months post-treatment, and 12 months post-treatment | Assessed using PROMIS-29 HRQOL questionnaires (Patient-Reported Outcomes Measurement Information System 29-item profile). Raw domain scores are converted to T-scores calibrated to the US general population, with a mean of 50 and standard deviation of 10. For symptom domains (anxiety, depression, fatigue, pain interference, sleep disturbance), higher scores indicate worse symptom burden. For functioning domains (physical function, social participation), higher scores indicate better functioning. Changes from baseline to 3 time points post-treatment will be analyzed. |
| Total in-room time | From patient entry to exit at the treatment console, approximately one day | The duration from patient entry to exit at the treatment console will be collected; summary statistics will be reported for entire cohort and sub-cohort of treated target number 1, 2 and 3, respectively. |
Countries
United States
Contacts
CONTACTCarol Felix
CONTACTChristy Palodichuk
PRINCIPAL_INVESTIGATORAnn Raldow, MD
UCLA / Jonsson Comprehensive Cancer Center
Outcome results
None listed