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

Jonsson Comprehensive Cancer Center

Status: Completed

Conditions: Lung Cancer

Treatments: Radiation: Radiofrequency Ablation; Radiation: Stereotactic Body Radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT01051037

09-08-026

10-000656 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Arm 1

Experimental group

Description:

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

Treatment:

Radiation: Stereotactic Body Radiation

Radiation: Radiofrequency Ablation