Two Radiation Dose Schedules of SBRT to Lung Metastases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-26

Study Completion Date

2018-08-09

Brief Summary

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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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Detailed Description

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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.

Conditions

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Neoplasm Metastasis Cancer Radiation Therapy Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

30 Gy single fraction SBRT 18 Gy x three fractions

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Fraction of SBRT

Stereotactic Body Radiation Therapy delivered in a single session on one day

Group Type EXPERIMENTAL

Stereotactic Body Radiation Therapy

Intervention Type RADIATION

Stereotactic Body Radiation Therapy using different fractionation schedules

Fractionated SBRT

Stereotactic Body Radiation Therapy delivered in three to five fractions with one fraction delivered every other day

Group Type EXPERIMENTAL

Stereotactic Body Radiation Therapy

Intervention Type RADIATION

Stereotactic Body Radiation Therapy using different fractionation schedules

Interventions

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Stereotactic Body Radiation Therapy

Stereotactic Body Radiation Therapy using different fractionation schedules

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No