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

Primary Purpose

Lung Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Stereotactic Body Radiation

Radiofrequency Ablation

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring lung tumors, central airways

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UCLA Jonsson Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Achieve no more than 15% decline from the pre-treatment pulmonary function parameter (FEV1, DLCO) post-SBRT/RFA.

Achieve at least a 80% one-year local control (LC) rate by RECIST criterion or PET response (if applicable).

Progression-free survival

Overall survival

Concentration of serum TGF-B as early biomarker for treatment-inducted normal tissue injury

Concentration of serum VEGF as an early biomarker for response

Full Information

NCT ID

NCT01051037

First Posted

January 15, 2010

Last Updated

May 3, 2019

Sponsor

Jonsson Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT01051037

Brief Title

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

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

February 8, 2010 (Actual)

Primary Completion Date

December 20, 2017 (Actual)

Study Completion Date

December 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jonsson Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

lung tumors, central airways

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Body Radiation

Other Intervention Name(s)

SBR

Intervention Description

3 fraction of stereotactic body radiation therapy within 10 days.

Intervention Type

Radiation

Intervention Name(s)

Radiofrequency Ablation

Other Intervention Name(s)

RFA

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Achieve no more than 15% decline from the pre-treatment pulmonary function parameter (FEV1, DLCO) post-SBRT/RFA.

Time Frame

3 years

Title

Achieve at least a 80% one-year local control (LC) rate by RECIST criterion or PET response (if applicable).

Time Frame

3 years

Title

Progression-free survival

Time Frame

3 years

Title

Overall survival

Time Frame

3 years

Title

Concentration of serum TGF-B as early biomarker for treatment-inducted normal tissue injury

Time Frame

3 years

Title

Concentration of serum VEGF as an early biomarker for response

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Percy Lee, MD

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCLA Jonsson Comprehensive Cancer Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

12. IPD Sharing Statement

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

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