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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Jonsson Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01051037
First received: January 15, 2010
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Lung Cancer
Radiation: Stereotactic Body Radiation
Radiation: Radiofrequency Ablation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 35
Study Start Date: February 2010
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01051037

Contacts
Contact: Percy Lee, MD 310-206-6542

Locations
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
Investigators
Principal Investigator: Percy Lee, MD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01051037     History of Changes
Other Study ID Numbers: 09-08-026
Study First Received: January 15, 2010
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration

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
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 26, 2014