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

January 15, 2010
May 27, 2014
February 2010
August 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01051037 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • 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
Experimental: Arm 1
Subjects will undergo PET/CT simulation, 3 Fraction SBRT, RFA, and then undergo follow up.
Interventions:
  • Radiation: Stereotactic Body Radiation
  • Radiation: Radiofrequency Ablation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
35
Not Provided
August 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Percy Lee, MD 310-206-6542
United States
 
NCT01051037
09-08-026
Yes
Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center
Not Provided
Principal Investigator: Percy Lee, MD University of California, Los Angeles
Jonsson Comprehensive Cancer Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP