Clinical trial NCT00109876: Radiofrequency Ablation in Treating Patients With Stage I Non-Small Cell Lung Cancer
Official title: A Pilot Study of Radiofrequency Ablation in High-Risk Patients With Stage IA Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: stage I non-small cell lung cancer
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-05-04
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Overall Survival at 2 Years
timeFrame: 2 years from registration
Secondary outcomes:
measure: Overall Time to Local Failure
timeFrame: Up to 2 years
measure: Overall Time to Recurrence
timeFrame: Up to 2 years
measure: Number of Procedures Deemed Technical Successes
timeFrame: Up to 2 years
measure: Incidence of Adverse Events
timeFrame: Up to 2 years
measure: Change in Pulmonary Function From Baseline at Month 3
timeFrame: Baseline and Month 3
measure: Change in Pulmonary Function From Baseline at Month 24
timeFrame: Baseline and Month 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Comprehensive Cancer Center
state: Alabama
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center at UCLA
state: California
city: Sacramento
country: United States
facility: University of California Davis Cancer Center
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston University Cancer Research Center
state: Massachusetts
city: Royal Oak
country: United States
facility: William Beaumont Hospital - Royal Oak Campus
state: Michigan
city: Stony Brook
country: United States
facility: Stony Brook University Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: Good Samaritan Hospital Cancer Treatment Center
state: Ohio
city: Portland
country: United States
facility: Providence Cancer Center at Providence Portland Medical Center
state: Oregon
city: Providence
country: United States
facility: Rhode Island Hospital Comprehensive Cancer Center
state: Rhode Island
city: Chattanooga
country: United States
facility: H. Clay Evans Johnson Cancer Center at Memorial Hospital
state: Tennessee
city: Dallas
country: United States
facility: Medical City Dallas Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute at University of Utah
state: Utah
city: Spokane
country: United States
facility: Providence Cancer Center at Sacred Heart Medical Center
state: Washington
city: Spokane
country: United States
facility: Providence Cancer Center at Holy Family Hospital
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Cancer Center
state: Wisconsin
Study officials:
affiliation: Rhode Island Hospital
name: Damian E. Dupuy, MD
role: STUDY_CHAIR
References: