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

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Radiation: Stereotactic Body Radiation; Radiation: Radiofrequency Ablation

• Registration Number: NCT01051037
• Lead Sponsor: Jonsson Comprehensive Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-15
• Study First Submitted QC: 2010-01-15
• Study First Posted: 2010-01-18
• Study Start: 2010-02-08
• Primary Completion: 2017-12-20
• Study Completion: 2017-12-20
• Status Verified: 2018-04
• Last Update Submitted: 2019-05-03
• Last Update Posted: 2019-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Stereotactic Body Radiation	Subjects will undergo PET/CT simulation, 3 Fraction SBRT, RFA, and then undergo follow up.
Arm 1	Radiofrequency Ablation	Subjects will undergo PET/CT simulation, 3 Fraction SBRT, RFA, and then undergo follow up.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Concentration of serum VEGF as an early biomarker for response	3 years
Overall survival	3 years
Concentration of serum TGF-B as early biomarker for treatment-inducted normal tissue injury	3 years

Trial Locations

Locations (1)

UCLA Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States