Cancer, Neoplasm Metastasis, Radiation Therapy Complication
Conditions
Brief summary
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
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.
Interventions
RADIATIONStereotactic Body Radiation Therapy
Stereotactic Body Radiation Therapy using different fractionation schedules
Sponsors
Ronald McGarry
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
30 Gy single fraction SBRT 18 Gy x three fractions
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Disease Control Rates | 6 MONTHS | Response defined by the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1 |
Countries
United States
Outcome results
None listed