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

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: Lung Cancer
• Intervention / Treatment: Radiation: Stereotactic Body Radiation; Radiation: Radiofrequency Ablation

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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.	3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Investigators: Principal Investigator: Percy Lee, MD, University of California, Los Angeles

Study record dates

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: lung tumors; central airways
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 09-08-026; 10-000656 (Other Identifier: UCLA/Jonsson Comprehensive Cancer Center)