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

May 3, 2019 updated by: Jonsson Comprehensive Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Jonsson Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Subjects will undergo PET/CT simulation, 3 Fraction SBRT, RFA, and then undergo follow up.
Radiation: Stereotactic Body Radiation
3 fraction of stereotactic body radiation therapy within 10 days.
Other Names:
  • SBR
Radiation: Radiofrequency Ablation
Subject will undergo radiofrequency ablation within 10 days of the last fraction of SBRT.
Other Names:
  • RFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Achieve at most of 20% subacute or chronic grade 3 or higher lng, cardiac, or upper GI toxicity rate in patients treated with SBRT/RFA.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 3 years
3 years
Progression-free survival
Time Frame: 3 years
3 years
Achieve no more than 15% decline from the pre-treatment pulmonary function parameter (FEV1, DLCO) post-SBRT/RFA.
Time Frame: 3 years
3 years
Achieve at least a 80% one-year local control (LC) rate by RECIST criterion or PET response (if applicable).
Time Frame: 3 years
3 years
Concentration of serum TGF-B as early biomarker for treatment-inducted normal tissue injury
Time Frame: 3 years
3 years
Concentration of serum VEGF as an early biomarker for response
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Investigators

  • Principal Investigator: Percy Lee, MD, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2010

Primary Completion (Actual)

December 20, 2017

Study Completion (Actual)

December 20, 2017

Study Registration Dates

First Submitted

January 15, 2010

First Submitted That Met QC Criteria

January 15, 2010

First Posted (Estimate)

January 18, 2010

Study Record Updates

Last Update Posted (Actual)

May 6, 2019

Last Update Submitted That Met QC Criteria

May 3, 2019

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-08-026
  • 10-000656 (Other Identifier: UCLA/Jonsson Comprehensive Cancer Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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