Trial record 1 of 1 for:    NCT01051037
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Stereotactic Body Radiotherapy and Radiofrequency Ablation for Lung Tumors Near Central Airways

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01051037
Recruitment Status : Recruiting
First Posted : January 18, 2010
Last Update Posted : September 14, 2017
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Brief 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.

Condition or disease Intervention/treatment
Lung Cancer Radiation: Stereotactic Body Radiation Radiation: Radiofrequency Ablation

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Evaluating Safety and Efficacy of Stereotactic Body Radiotherapy and Radiofrequency Ablation for Medically Inoperable and Recurrent Lung Tumors Near Central Airways
Actual Study Start Date : February 8, 2010
Estimated Primary Completion Date : February 8, 2018
Estimated Study Completion Date : February 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

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 Name: SBR
Radiation: Radiofrequency Ablation
Subject will undergo radiofrequency ablation within 10 days of the last fraction of SBRT.
Other Name: RFA

Primary Outcome Measures :
  1. 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01051037

Contact: Percy Lee, MD 310-206-6542

United States, California
UCLA Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Percy Lee, MD    310-206-6542      
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Principal Investigator: Percy Lee, MD University of California, Los Angeles

Responsible Party: Jonsson Comprehensive Cancer Center Identifier: NCT01051037     History of Changes
Other Study ID Numbers: 09-08-026
First Posted: January 18, 2010    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017

Keywords provided by Jonsson Comprehensive Cancer Center:
lung tumors
central airways

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases