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

NCT ID: NCT00109876

Last Updated: 2017-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2013-02-28

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation

Intervention Type: PROCEDURE

Undergo RFA

Interventions

Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation

Undergo RFA

Intervention Type: PROCEDURE

Other Intervention Names

CT-guided optical sensor-guided radiofrequency ablation, CT-guided optical sensor-guided RF ablation

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Damian E. Dupuy, MD

Role: STUDY_CHAIR

Rhode Island Hospital

Locations

UAB Comprehensive Cancer Center

Birmingham, Alabama, United States

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, United States

University of California Davis Cancer Center

Sacramento, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Boston University Cancer Research Center

Boston, Massachusetts, United States

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, United States

Stony Brook University Cancer Center

Stony Brook, New York, United States

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Good Samaritan Hospital Cancer Treatment Center

Cincinnati, Ohio, 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

H. Clay Evans Johnson Cancer Center at Memorial Hospital

Chattanooga, Tennessee, United States

Medical City Dallas Hospital

Dallas, Texas, United States

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, United States

Providence Cancer Center at Sacred Heart Medical Center

Spokane, Washington, United States

Providence Cancer Center at Holy Family Hospital

Spokane, Washington, United States

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

ACOSOG-Z4033

Identifier Type: -

Identifier Source: secondary_id

CDR0000426417

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACOSOG-Z4033

Identifier Type: -

Identifier Source: org_study_id