Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. Computed tomography (CT)-guided radiofrequency ablation may be an effective treatment for non-small cell lung cancer.

PURPOSE: This phase II trial is studying how well radiofrequency ablation works in treating patients with stage I non-small cell lung cancer.

Further Study Information

OBJECTIVES:

Primary

• Determine the overall 2-year survival rate after radiofrequency ablation (RFA) of lung nodules in high-risk patients with stage IA non-small cell lung cancer.

Secondary

• Determine freedom from regional or distant recurrence in patients treated with this regimen.

• Determine freedom from local recurrence in the ablated lobe at 2 years in these patients.

• Determine the number of procedures deemed technical successes in patients treated with this regimen.

• Determine procedure-specific morbidity and mortality.

• Determine the utility of immediate (within 96 hours) post-RFA positron emission tomography (PET) in predicting overall survival and local control in these patients.

• Determine the effect of RFA on short-term (3 months post-RFA) and long-term (24 months post-RFA) pulmonary function in these patients.

OUTLINE: This is a multicenter, pilot study.

A radiofrequency electrode is placed by CT guidance into the target tumor. Patients undergo radiofrequency ablation (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. Patients undergo fludeoxyglucose F18 positron emission tomography within 24-96 hours after the final treatment.

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

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 20 months.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

• Clinical stage IA disease

• Tumor mass ≤ 3 cm in largest dimension by CT scan of the lung

• Tumor noncontiguous with vital structures (i.e., trachea, esophagus, aorta, aortic arch branches, or heart)

• Tumor accessible by percutaneous transthoracic route

• Previously untreated disease

• Not a candidate for traditional lobectomy due to comorbid medical condition(s)

• Must have undergone evaluation by a thoracic surgeon and was determined to be at high-risk for surgical resection of the lung

• All suspicious mediastinal lymph nodes (> 1 cm short-axis dimension by CT scan OR positive by positron emission tomography) must be confirmed negative for involvement with NSCLC by 1 of the following methods:

• Mediastinoscopy

• Endo-esophageal ultrasound-guided needle aspiration

• CT-guided, video-assisted thoracoscopic OR open lymph node biopsy

• Meets ≥ 1 of the following major criteria OR ≥ 2 of the following minor criteria:

• Major criteria:

• FEV1 ≤ 50% of predicted

• DLCO ≤ 50% of predicted

• Minor criteria:

• Age 75 and over

• FEV1 51-60% of predicted

• DLCO 51-60% of predicted

• Pulmonary hypertension, defined as pulmonary artery systolic pressure > 40 mm Hg, by echocardiogram or right heart catheterization

• Poor left ventricular function, defined as ejection fraction ≤ 40%

• Resting or exercise arterial pO_2 ≤ 55 mm Hg OR SpO_2 ≤ 88%

• pCO_2 > 45 mm Hg

• Modified Medical Research Council Dyspnea Scale ≥ grade 3

PATIENT CHARACTERISTICS:

Age

• Over 18

Performance status

• ECOG 0-2 OR

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Cardiovascular

• See Disease Characteristics

Pulmonary

• See Disease Characteristics

Other

• Negative pregnancy test

• No other medical condition that would preclude study participation

• No other malignancy within the past 5 years except previously treated basal cell carcinoma or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• No prior intrathoracic radiotherapy

Surgery

• Not specified

Trial Contact Information

Trial Lead Organizations/Sponsors

American College of Surgeons

Damian E. Dupuy

Study Chair

Kamran Ahrar

Robert D. Suh

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00109876
Information obtained from ClinicalTrials.gov on February 13, 2013

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