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

Lung Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01051037
• Other study ID #: 09-08-026
• Secondary ID: 10-000656
• Status: Completed
• Phase: N/A
• Start date: February 8, 2010
• Est. completion date: December 20, 2017

Study information

• Verified date: April 2018
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 20, 2017
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Radiation:
• Stereotactic Body Radiation
3 fraction of stereotactic body radiation therapy within 10 days.
• Radiofrequency Ablation
Subject will undergo radiofrequency ablation within 10 days of the last fraction of SBRT.

Locations

Country	Name	City	State
United States	UCLA Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 years
Secondary	Achieve no more than 15% decline from the pre-treatment pulmonary function parameter (FEV1, DLCO) post-SBRT/RFA.		3 years
Secondary	Achieve at least a 80% one-year local control (LC) rate by RECIST criterion or PET response (if applicable).		3 years
Secondary	Progression-free survival		3 years
Secondary	Overall survival		3 years
Secondary	Concentration of serum TGF-B as early biomarker for treatment-inducted normal tissue injury		3 years
Secondary	Concentration of serum VEGF as an early biomarker for response		3 years