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

NCT ID: NCT01051037

Last Updated: 2019-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-08
• Study Completion Date: 2017-12-20

Brief 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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

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

Group Type: EXPERIMENTAL

Stereotactic Body Radiation

Intervention Type: RADIATION

3 fraction of stereotactic body radiation therapy within 10 days.

Radiofrequency Ablation

Intervention Type: RADIATION

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

Interventions

Stereotactic Body Radiation

3 fraction of stereotactic body radiation therapy within 10 days.

Intervention Type: RADIATION

Radiofrequency Ablation

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

Intervention Type: RADIATION

Other Intervention Names

SBR; RFA

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Percy Lee, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

10-000656

Identifier Type: OTHER

Identifier Source: secondary_id

09-08-026

Identifier Type: -

Identifier Source: org_study_id