Two Radiation Dose Schedules of SBRT to Lung Metastases < 5cm in Dimension

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.

Study Overview

• Status: Withdrawn
• Conditions: Cancer; Neoplasm Metastasis; Radiation Therapy Complication
• Intervention / Treatment: Radiation: Stereotactic Body Radiation Therapy

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Fraction of SBRT; Stereotactic Body Radiation Therapy delivered in a single session on one day	Radiation: Stereotactic Body Radiation Therapy; Stereotactic Body Radiation Therapy using different fractionation schedules
Experimental: Fractionated SBRT; Stereotactic Body Radiation Therapy delivered in three to five fractions with one fraction delivered every other day	Radiation: Stereotactic Body Radiation Therapy; Stereotactic Body Radiation Therapy using different fractionation schedules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Disease Control Rates	Response defined by the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1	6 MONTHS

Collaborators and Investigators

• Sponsor: Ronald McGarry
• Investigators: Principal Investigator: Ronald McGarry, MD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2017
• Primary Completion (Actual): July 20, 2018
• Study Completion (Actual): August 9, 2018

Study Registration Dates

• First Submitted: January 20, 2017
• First Submitted That Met QC Criteria: January 20, 2017
• First Posted (Estimate): January 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 15, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: MCC-16-MULTI-21; MCC-16-LUN-101 (Other Identifier: Univ of KY Markey Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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