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

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Procedure: Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • UAB Comprehensive Cancer Center
  • California
    • Los Angeles, California, United States, 90095-1781
      • Jonsson Comprehensive Cancer Center at UCLA
    • Sacramento, California, United States, 95817
      • University of California Davis Cancer Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02118
      • Boston University Cancer Research Center
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital - Royal Oak Campus
  • New York
    • Stony Brook, New York, United States, 11794-9446
      • Stony Brook University Cancer Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7295
      • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan Hospital Cancer Treatment Center
  • Oregon
    • Portland, Oregon, United States, 97213-2967
      • Providence Cancer Center at Providence Portland Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital Comprehensive Cancer Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • H. Clay Evans Johnson Cancer Center at Memorial Hospital
  • Texas
    • Dallas, Texas, United States, 75230
      • Medical City Dallas Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute at University of Utah
  • Washington
    • Spokane, Washington, United States, 99204
      • Providence Cancer Center at Sacred Heart Medical Center
    • Spokane, Washington, United States, 99207
      • Providence Cancer Center at Holy Family Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (RFA therapy); 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.	Procedure: Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation; Undergo RFA; Other Names: CT-guided optical sensor-guided radiofrequency ablation, CT-guided optical sensor-guided RF ablation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Time to Local Failure	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.	Up to 2 years
Overall Time to Recurrence	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.	Up to 2 years
Number of Procedures Deemed Technical Successes	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.	Up to 2 years
Incidence of Adverse Events	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.	Up to 2 years
Change in Pulmonary Function From Baseline at 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.	Baseline and Month 3
Change in Pulmonary Function From Baseline at 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.	Baseline and Month 24

Collaborators and Investigators

• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: May 3, 2005
• First Submitted That Met QC Criteria: May 3, 2005
• First Posted (Estimate): May 4, 2005

Study Record Updates

• Last Update Posted (Actual): March 8, 2017
• Last Update Submitted That Met QC Criteria: January 26, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: stage I non-small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: ACOSOG-Z4033; CDR0000426417 (Registry Identifier: NCI Physician Data Query)