Two Radiation Dose Schedules of SBRT to Lung Metastases < 5cm in Dimension

Study Overview
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Brief Summary
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30 Gy single fraction of SBRT for lung metastases will result in comparable oncologic outcomes to 18Gy in three fractions (or dosing to a BED </-100Gy at the discretion of the radiation oncologist) with respect to disease control and toxicity.

Detailed Description
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Using two different doses of SBRT, this study will examine the 6-month local disease control rate (LDCR) of the SBRT-treated metastasis to determine the optimum dosing for SBRT in pulmonary metastases. This will allow us to establish baseline SBRT data, from which we will develop a second trial to examine sequencing of immunotherapy with SBRT.

Official Title
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A Randomized Phase 2 Study of Two Radiation Dose Schedules of Stereotactic Body Radiotherapy (SBRT) to Lung Metastases < 5cm in Dimension

Conditions
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Neoplasm Metastasis, Cancer, Radiation Therapy Complication

Intervention / Treatment
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* Radiation: Stereotactic Body Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological confirmation of malignant carcinoma/sarcoma (any site) with metastasis to lung. Patients must not be eligible for therapy with curative intent (i.e. surgery, radiation, etc). Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension Age ≥18 years ECOG performance status >/= 2 (Karnofsky≥60%)). Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Patients with more than >/=3 metastatic lung lesions or any one lesion greater than 5 cm. and/or extensive metastatic disease outside the chest. Patients who are receiving any other investigational agents. Patients with active systemic, pulmonary, or pericardial infection. Pregnant or lactating women Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Chemotherapy concurrent with SBRT is not allowed

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: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 30 Gy single fraction SBRT 18 Gy x three fractions
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Fraction of SBRT<br>Stereotactic Body Radiation Therapy delivered in a single session on one day | Radiation: Stereotactic Body Radiation Therapy<br>* Stereotactic Body Radiation Therapy using different fractionation schedules<br>|
| Experimental: Fractionated SBRT<br>Stereotactic Body Radiation Therapy delivered in three to five fractions with one fraction delivered every other day | Radiation: Stereotactic Body Radiation Therapy<br>* Stereotactic Body Radiation Therapy using different fractionation schedules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Disease Control Rates | Response defined by the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1 | 6 MONTHS |