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

Phase II Study Evaluating Safety and Efficacy of Stereotactic Body Radiotherapy and Radiofrequency Ablation for Medically Inoperable and Recurrent Lung Tumors Near Central Airways

NCT01051037•Jonsson Comprehensive Cancer Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion 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
+4 more criteria

Exclusion Criteria

•Prior thoracic radiation near the targets of interest
•More than 2 central tumor targets per patient
•Active infections requiring systemic antibiotics

Locations (1)

UCLA Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Key Dates

Start Date

February 8, 2010

Primary Completion Date

December 20, 2017

Completion Date

December 20, 2017

Last Updated

May 6, 2019

Enrollment

ACTUAL participants

Conditions

Lung Cancer

Interventions

Stereotactic Body Radiation

RADIATION

Radiofrequency Ablation

RADIATION

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 6, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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