Two Radiation Dose Schedules of SBRT to Lung Metastases < 5cm in Dimension
Status: | Withdrawn |
---|---|
Conditions: | Cancer, Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/17/2018 |
Start Date: | October 26, 2017 |
End Date: | August 9, 2018 |
A Randomized Phase 2 Study of Two Radiation Dose Schedules of Stereotactic Body Radiotherapy (SBRT) to Lung Metastases < 5cm in Dimension
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.
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.
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.
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.
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
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University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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