Clinical trial NCT01051037: Stereotactic Body Radiotherapy and Radiofrequency Ablation for Lung Tumors Near Central Airways
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: lung tumors
central airways
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2010-01-18
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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.
timeFrame: 3 years
Secondary outcomes:
measure: Achieve no more than 15% decline from the pre-treatment pulmonary function parameter (FEV1, DLCO) post-SBRT/RFA.
timeFrame: 3 years
measure: Achieve at least a 80% one-year local control (LC) rate by RECIST criterion or PET response (if applicable).
timeFrame: 3 years
measure: Progression-free survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
measure: Concentration of serum TGF-B as early biomarker for treatment-inducted normal tissue injury
timeFrame: 3 years
measure: Concentration of serum VEGF as an early biomarker for response
timeFrame: 3 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Percy Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: