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CompletedNot applicableNCT01051037
Official study title

Stereotactic Body Radiotherapy and Radiofrequency Ablation for Lung Tumors Near Central Airways

Study summary

The purpose of this study is to demonstrate that combined stereotactic body radiotherapy and radiofrequency ablation is safe for patients with lung tumors near central airways.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedStereotactic Body Radiation and Radiofrequency Ablation

The study team can explain what participation involves.

Who it may be forLung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 6, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Jonsson Comprehensive Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
Jonsson Comprehensive Cancer Center
Interventions being studied
Radiation: Stereotactic Body Radiation; Radiation: Radiofrequency Ablation
02
Explore related studies

How this study is categorized

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

Treatment approach
Radiation therapy→
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
  • Histologically confirmed primary lung cancer, lung metastasis from another primary, or recurrent tumors in the setting of prior RFA or cryotherapy
  • Tumors \< 2 cm from trachea or zone of proximal bronchial tree (central tumors)
  • Each tumor \< 5 cm in size prior to treatment
  • Medically inoperable patients as determined at the multidisciplinary thoracic tumor board, or medically operable patients who refuse surgery
  • Criterion for medical inoperability include:
  • Overall clinical assessment at the UCLA thoracic tumor board
  • Reduced Pulmonary Function (FEV1, DLCO, etc) based on one major or two minor criterion as described below:
  • Modified ACOSOG Criteria for medical inoperability:
  • Major Criteria: FEV1% \< 50% or \< 1L and DLCO \< 50%
  • Minor Criteria: Age \> 75, FEV1 51-60% predicted, or FEV1 1-1.2L, DLCO 51%-60% predicted, pulmonary hypertension, poor left ventricular function (EF \< 40% or less), resting or exercise arterial pO2 \< 55 mmHg, and pCO2 \> 45 mmHg
  • Age \> 18 years old
  • KPS \> 70
  • If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented.
  • Ability to understand and the willingness to sign a written informed consent
Reasons someone may not be able to joinExclusion criteria
  • Prior thoracic radiation near the targets of interest
  • More than 2 central tumor targets per patient
  • Active infections requiring systemic antibiotics

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

  • UCLA Jonsson Comprehensive Cancer CenterLos Angeles, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 6, 2019. Always confirm current availability with the study team.

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