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Completed

NCT Number: NCT01051037

Stereotactic Body Radiotherapy and Radiofrequency Ablation for 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stereotactic Body Radiation

Radiation

3 fraction of stereotactic body radiation therapy within 10 days.

Other names: SBR

radiofrequency ablation

Radiation

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

Other names: RFA

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

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Jan 18, 2010
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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