Back to resultsTwo Radiation Dose Schedules of SBRT to Lung Metastases < 5cm in Dimension
Primary Purpose
Neoplasm Metastasis, Cancer, Radiation Therapy Complication
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Body Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasm Metastasis
Eligibility Criteria
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
Sites / Locations
- University of Kentucky
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Single Fraction of SBRT
Fractionated SBRT
Arm Description
Stereotactic Body Radiation Therapy delivered in a single session on one day
Stereotactic Body Radiation Therapy delivered in three to five fractions with one fraction delivered every other day
Outcomes
Primary Outcome Measures
Local Disease Control Rates
Response defined by the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03029416
Brief Title
Two Radiation Dose Schedules of SBRT to Lung Metastases < 5cm in Dimension
Official Title
A Randomized Phase 2 Study of Two Radiation Dose Schedules of Stereotactic Body Radiotherapy (SBRT) to Lung Metastases < 5cm in Dimension
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Why Stopped
PRMC Administrative Disapproval - Slow accrual
Study Start Date
October 26, 2017 (Actual)
Primary Completion Date
July 20, 2018 (Actual)
Study Completion Date
August 9, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ronald McGarry
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm Metastasis, Cancer, Radiation Therapy Complication
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
30 Gy single fraction SBRT 18 Gy x three fractions
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Fraction of SBRT
Arm Type
Experimental
Arm Description
Stereotactic Body Radiation Therapy delivered in a single session on one day
Arm Title
Fractionated SBRT
Arm Type
Experimental
Arm Description
Stereotactic Body Radiation Therapy delivered in three to five fractions with one fraction delivered every other day
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy
Intervention Description
Stereotactic Body Radiation Therapy using different fractionation schedules
Primary Outcome Measure Information:
Title
Local Disease Control Rates
Description
Response defined by the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1
Time Frame
6 MONTHS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald McGarry, MD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Two Radiation Dose Schedules of SBRT to Lung Metastases < 5cm in Dimension
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