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

Not Applicable

Completed

Conditions: Lung Cancer

Interventions: Procedure: Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation

Registration Number: NCT00109876

Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief 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.

Detailed 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 & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 54

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)

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (RFA therapy)	Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation	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° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.

Primary Outcome Measures

Name	Time	Method
Overall Survival at 2 Years	2 years from registration	Percentage of participants who were alive at 2 years. The 2 year survival was estimated using the Kaplan Meier method.

Secondary Outcome Measures

Name	Time	Method
Overall Time to Recurrence	Up to 2 years	The overall time to recurrence was defined as the time from registration to documentation of disease recurrence. If a patient dies without a documentation of disease recurrence, the patient will be considered to have had tumor recurrence at the time of their death unless there is sufficient evidence to conclude no recurrence occurred prior to death.
Overall Time to Local Failure	Up to 2 years	The overall time to local failure was defined as the time from registration to documentation of \> local failure. The local failure was defined as the recurrence in the same lobe or hilum (N1 nodes) or progression at the ablated site after treatment affects have subsided.
Change in Pulmonary Function From Baseline at Month 24	Baseline and Month 24	Pulmonary function test values include forced expiratory volume 1 (FEV1) and carbon monoxide diffusion (DLCO). The distribution of clinically meaningful changes (10% increase or 10% decrease) in pulmonary function from the baseline to 24 was summarized.
Incidence of Adverse Events	Up to 2 years	The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 was used to evaluate adverse event.\> Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.
Change in Pulmonary Function From Baseline at Month 3	Baseline and Month 3	Pulmonary function test values include forced expiratory volume 1 (FEV1) and carbon monoxide diffusion (DLCO). The distribution of clinically meaningful changes (10% increase or 10% decrease) in pulmonary function from the baseline to 3 was summarized.
Number of Procedures Deemed Technical Successes	Up to 2 years	The number of procedures deemed technical successes is defined as the number of patients with a RFA procedures deemed a technical success. A technical success is defined as follows: The pertinent 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) were reviewed by the quality control panel to determine technical success.

Trial Locations

Locations (17): Jonsson Comprehensive Cancer Center at UCLA
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Los Angeles, California, United States
Massachusetts General Hospital
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Boston, Massachusetts, United States
Stony Brook University Cancer Center
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Stony Brook, New York, United States
Good Samaritan Hospital Cancer Treatment Center
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Cincinnati, Ohio, United States
Boston University Cancer Research Center
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Boston, Massachusetts, United States
Providence Cancer Center at Providence Portland Medical Center
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Portland, Oregon, United States
H. Clay Evans Johnson Cancer Center at Memorial Hospital
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Chattanooga, Tennessee, United States
William Beaumont Hospital - Royal Oak Campus
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Royal Oak, Michigan, United States
UAB Comprehensive Cancer Center
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Birmingham, Alabama, United States
University of California Davis Cancer Center
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Sacramento, California, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Chapel Hill, North Carolina, United States
Rhode Island Hospital Comprehensive Cancer Center
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Providence, Rhode Island, United States
Huntsman Cancer Institute at University of Utah
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Salt Lake City, Utah, United States
Medical City Dallas Hospital
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Dallas, Texas, United States
Providence Cancer Center at Sacred Heart Medical Center
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Spokane, Washington, United States
Medical College of Wisconsin Cancer Center
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Milwaukee, Wisconsin, United States
Providence Cancer Center at Holy Family Hospital
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Spokane, Washington, United States