Radiofrequency Ablation in Treating Patients With Stage I Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

A Pilot Study of Radiofrequency Ablation in High-Risk Patients With Stage IA Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00109876
• Other study ID #: ACOSOG-Z4033
• Secondary ID: ACOSOG-Z4033CDR0
• Status: Active, not recruiting
• Phase: N/A
• First received: May 3, 2005
• Last updated: July 1, 2016
• Start date: September 2006

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This pilot clinical trial studies how well radiofrequency ablation works in treating patients with stage IA non-small cell lung cancer. Radiofrequency ablation uses high-frequency electric current to kill tumor cells. Computed tomography (CT)-guided radiofrequency ablation may be a better treatment for non-small cell lung cancer.

Description:

PRIMARY OBJECTIVES:

I. To assess the overall 2-year survival rate after radiofrequency ablation (RFA).

SECONDARY OBJECTIVES:

I. To assess freedom from regional or distant recurrence. II. To assess freedom from local recurrence in the ablated lobe. III. To estimate the number of procedures deemed technical successes. IV. To evaluate procedure-specific morbidity and mortality. V. To explore the utility of immediate (within 96 hours) post-RFA positron emission tomography (PET) in predicting overall survival and local control.

VI. To explore the effect of RFA on both short-term (3 months post-RFA) and long-term (24 months post-RFA) pulmonary function.

OUTLINE:

A radiofrequency electrode is placed by CT guidance into the target tumor. Patients undergo RFA directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° Celsius (C). Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 1 year.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• PRE-REGISTRATION CRITERIA:

• Patients must have a lung nodule suspicious for clinical stage I non-small cell lung cancer (NSCLC)

• Patient must have a mass =< 3 cm maximum diameter by CT size estimate: clinical stage IA

• Patient must have been evaluated by a thoracic surgeon and been deemed at high risk for a lung resection; NOTE: if the evaluating surgeon is not a member of American College of Surgeons Oncology Group (ACOSOG), then an ACOSOG thoracic surgeon must confirm with dated signature that the patient is high-risk and appropriate for RFA

• Patient must have fludeoxyglucose F 18 (FDG)-PET and a CT scan of the chest with upper abdomen within 60 days prior to pre-registration; patient must have pulmonary function tests (PFTs) within 120 days prior to registration

• Patient must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0, 1, or 2

• Patient must meet at least one major criterion or meet a minimum of two minor criteria as described below:

• Major criteria

• Forced expiratory volume in one second (FEV1) =< 50% predicted

• Diffusing capacity of the lung for carbon monoxide (DLCO) =< 50% predicted

• Minor Criteria

• Age >= 75

• FEV1 51-60% predicted

• DLCO 51-60% predicted

• Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mmHg) as estimated by echocardiography or right heart catheterization

• Poor left ventricular function (defined as an ejection fraction of 40% or less)

• Resting or exercise arterial partial pressure of oxygen (pO2) =< 55 mmHg or oxygen saturation (SpO2) =< 88%

• Partial pressure of carbon dioxide (pCO2) > 45 mmHg

• Modified Medical Research Council (MMRC) Dyspnea Scale >= 3

• Patient must not have had previous intra-thoracic radiation therapy

• Women of child-bearing potential must have negative serum or urine pregnancy test within 2 weeks of registration

• REGISTRATION ACTIVATION CRITERIA:

• Patient must have histologically or cytologically proven NSCLC, 3 cm or smaller, as determined by the largest dimension on CT lung windows

• Patient's tumor must be non-contiguous with vital structures: trachea, esophagus, aorta, aortic arch branches and heart and lesions must be accessible via percutaneous transthoracic route

• Patient must have all suspicious mediastinal lymph nodes (> 1 cm short-axis dimension on CT scan or positive on PET scan) assessed by the following to confirm negative involvement with NSCLC (mediastinoscopy, endo-esophageal ultrasound-guided needle aspiration, CT-guided, video-assisted thoracoscopic or open lymph node biopsy)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation
Undergo RFA

Locations

Country	Name	City	State
United States	UAB Comprehensive Cancer Center	Birmingham	Alabama
United States	Boston University Cancer Research Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	H. Clay Evans Johnson Cancer Center at Memorial Hospital	Chattanooga	Tennessee
United States	Good Samaritan Hospital Cancer Treatment Center	Cincinnati	Ohio
United States	Medical City Dallas Hospital	Dallas	Texas
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon
United States	Rhode Island Hospital Comprehensive Cancer Center	Providence	Rhode Island
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	University of California Davis Cancer Center	Sacramento	California
United States	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah
United States	Providence Cancer Center at Holy Family Hospital	Spokane	Washington
United States	Providence Cancer Center at Sacred Heart Medical Center	Spokane	Washington
United States	Stony Brook University Cancer Center	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		At 2 years	No
Secondary	Overall time to local failure		up to 2 years	No
Secondary	Overall time to recurrence		assessed up to 2 years	No
Secondary	Proportion of technical success assessed by captured images from the treatment CT showing RFA electrode placement and the recorded RFA generator parameters (e.g., impedance, current, power, treatment time and maximum intra-tumoral temperature)		Up to 2 years	No
Secondary	Incidence of adverse events using the Common Terminology Criteria for Adverse Events version 3.0		Up to 2 years	Yes
Secondary	Change in pulmonary function		Baseline to up to 2 years	No