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Phase II Study Evaluating Safety and Efficacy of Stereotactic Body Radiotherapy and Radiofrequency Ablation for Medically Inoperable and Recurrent Lung Tumors Near Central Airways


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Phase II Study Evaluating Safety and Efficacy of Stereotactic Body Radiotherapy and Radiofrequency Ablation for Medically Inoperable and Recurrent Lung Tumors Near Central Airways


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Percy Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Los Angeles

Authority:

United States: Food and Drug Administration

Study ID:

09-08-026

NCT ID:

NCT01051037

Start Date:

February 2010

Completion Date:

Related Keywords:

  • Lung Cancer
  • lung tumors
  • central airways
  • Lung Neoplasms

Name

Location

UCLA Jonsson Comprehensive Cancer CenterLos Angeles, California  90095