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CompletedNCT01051037Updated May 6, 2019

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

An interventional study of Stereotactic Body Radiation and Radiofrequency Ablation in Lung Cancer, sponsored by Jonsson Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-06.

Sponsored by Jonsson Comprehensive Cancer Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lung Cancer

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Keywords

  • lung tumors
  • central airways
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 17 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Jonsson Comprehensive Cancer Center is the lead sponsor of 396 studies on the registry; 67 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Prior thoracic radiation near the targets of interest
  • More than 2 central tumor targets per patient
  • Active infections requiring systemic antibiotics
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    Arm 1

    Subjects will undergo PET/CT simulation, 3 Fraction SBRT, RFA, and then undergo follow up.

    Radiation: Stereotactic Body Radiation · Radiation: Radiofrequency Ablation

Interventions

  • RadiationStereotactic Body Radiation

    3 fraction of stereotactic body radiation therapy within 10 days.

    Also known as: SBR

  • RadiationRadiofrequency Ablation

    Subject will undergo radiofrequency ablation within 10 days of the last fraction of SBRT.

    Also known as: RFA

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • UCLA Jonsson Comprehensive Cancer Center
    Los Angeles, California 90095, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01051037
Lead sponsor
Jonsson Comprehensive Cancer Center
Responsible party
Sponsor
First posted
Jan 18, 2010
Start date
Feb 8, 2010
Primary completion
Dec 20, 2017
Completion
Dec 20, 2017
Last update
May 6, 2019

Study contacts

Percy Lee, MD
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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