Single-Fraction SBRT Versus Standard Palliative Radiation Therapy in Treating Patients With Metastatic Cancer

Study Overview
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Brief Summary
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This phase II trial studies how well single-fraction stereotactic body radiation therapy (SBRT) works when compared to standard radiation therapy in treating patients with cancer that has spread to other places in the body (metastatic). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.

Detailed Description
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PRIMARY OBJECTIVES: I. To assess patient-reported pain response and quality of life (QoL) in patients randomized to either single-fraction stereotactic body radiation therapy (SBRT) or non-SBRT palliative radiation therapy for metastatic disease. SECONDARY OBJECTIVES: I. Compare overall survival for patients undergoing single fraction SBRT versus non-SBRT palliative radiation therapy. EXPLORATORY OBJECTIVES: I. Assess for changes in immune markers. II. Assess toxicity related to radiation treatment. III. Assess change in frailty index and cognitive function over time in patients undergoing treatment for metastatic cancer. IV. Evaluate the effect of circadian rhythm and radiation treatment time on outcomes. V. Assess the utility of the Pain Catastrophizing Index in patients undergoing radiation treatment for metastatic cancer. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo 1, 3-5, 5-6, or 10 fractions of palliative radiation therapy (RT) deemed appropriate by the treating physician. ARM II: Patients undergo single fraction SBRT. After completion of study treatment, patients may be followed up at 5 and 12 weeks.

Official Title
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A Phase 2 Randomized Study With a Non-randomized Cohort : Assessing Single-Fraction SBRT Versus Standard Palliative Radiation in Patients With Metastatic Disease (ASTEROID)

Conditions
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Metastatic Malignant Neoplasm

Intervention / Treatment
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* Radiation: Palliative Radiation Therapy
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Radiation: Stereotactic Body Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed malignancy Clinical or pathologic evidence of metastatic disease A site of malignant disease causing symptoms, or for which symptoms are imminent, in which radiation may be used for relief or prophylaxis Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately Participants with synchronous primary malignancies must have either: 1) documented control of their second malignancy or 2) have pathological confirmation of the metastatic lesion/disease site being targeted Participant must be willing and able to participate in protocol requirements, including pre- and post-treatment survey evaluations and clinical assessments Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: Prior radiation therapy targeting the same area for which radiation treatment is being planned (i.e., re-irradiation to a specific site of metastatic disease) Participants with known brain metastases Pregnant or nursing female participants Participants who are unable to accurately or reliably recount their pain medication regimens, including type, amount, or frequency of pain medication usage Participants who require or are being planned for surgical stabilization or metastasectomy of the planned radiation site Severe, active co-morbidity defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months; Transmural myocardial infarction within the last 3 months; Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration Unwilling or unable to follow protocol requirements Any condition which, in the investigator?s opinion, deems the patient unable to participate in enrollment Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (palliative RT)<br>Patients undergo 1, 3-5, 5-6, or 10 fractions of palliative RT deemed appropriate by the treating physician. | Radiation: Palliative Radiation Therapy<br>* Undergo palliative RT<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm II (SBRT)<br>Patients undergo single fraction SBRT. | Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Radiation: Stereotactic Body Radiation Therapy<br>* Undergo SBRT<br>* Other names: Stereotactic Ablative Body Radiation Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain responses | Will be quantified using the pain scales from the Brief Pain Inventory (BPI). Will be an analysis-of-covariance. | Baseline up to 12 weeks | 
| Change in Quality of life | Will be measured with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Will be an analysis-of-covariance. | Baseline up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Will be assessed by chart review. Will be carried out using a Cox proportional hazards regression model. | Up to date of last follow-up or date of death, at the time of study analysis, assessed up to 12 weeks |