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

Jonsson Comprehensive Cancer Center1 site in 1 country17 target enrollmentFebruary 8, 2010

ConditionsLung Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Lung Cancer
Sponsor: Jonsson Comprehensive Cancer Center
Enrollment: 17
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 8, 2010

End Date

December 20, 2017

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Jonsson Comprehensive Cancer Center

Responsible Party

Sponsor

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

Exclusion Criteria

•Prior thoracic radiation near the targets of interest
•More than 2 central tumor targets per patient
•Active infections requiring systemic antibiotics

Outcomes

Primary Outcomes

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

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