Cancer Clinical Trial
Official title:
A Randomized Phase 2 Study of Two Radiation Dose Schedules of Stereotactic Body Radiotherapy (SBRT) to Lung Metastases < 5cm in Dimension
Verified date | October 2018 |
Source | University of Kentucky |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 9, 2018 |
Est. primary completion date | July 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Kentucky | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Ronald McGarry |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Local Disease Control Rates | Response defined by the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1 | 6 MONTHS |
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