WithdrawnPhase 2NCT03029416
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedStereotactic Body Radiation Therapy

The study team can explain what participation involves.

Who it may be forNeoplasm Metastasis · Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 15, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Withdrawn

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Ronald McGarry

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Ronald McGarry
Interventions being studied
Radiation: Stereotactic Body Radiation Therapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of KentuckyLexington, Kentucky

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 15, 2018. Always confirm current availability with the study team.

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