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Status:Withdrawn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

Use our guide to learn which trials are right for you!

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 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.

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
We found this trial at
1
site
Lexington, Kentucky
859) 257-9000
Phone: 859-323-6486
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
?
mi
from
Lexington, KY
Click here to add this to my saved trials