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

Sponsor
Ronald McGarry (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03029416
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
9.4
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Stereotactic Body Radiation Therapy
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
30 Gy single fraction SBRT 18 Gy x three fractions30 Gy single fraction SBRT 18 Gy x three fractions
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase 2 Study of Two Radiation Dose Schedules of Stereotactic Body Radiotherapy (SBRT) to Lung Metastases < 5cm in Dimension
Actual Study Start Date :
Oct 26, 2017
Actual Primary Completion Date :
Jul 20, 2018
Actual Study Completion Date :
Aug 9, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Local Disease Control Rates [6 MONTHS]

    Response defined by the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Kentucky Lexington Kentucky United States 40536

Sponsors and Collaborators

  • Ronald McGarry

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ronald McGarry, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier:
NCT03029416
Other Study ID Numbers:
  • MCC-16-MULTI-21
  • MCC-16-LUN-101
First Posted:
Jan 24, 2017
Last Update Posted:
Oct 15, 2018
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Neoplasm Metastasis

Study Results

No Results Posted as of Oct 15, 2018