A Pilot Study of Radiofrequency Ablation in High-Risk Patients With Stage IA Non-Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
A Pilot Study of Radiofrequency Ablation in High-Risk Patients With Stage IA Non-Small Cell Lung Cancer
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Overall survival at 2 years
Safety Issue:
No
Principal Investigator
Damian E. Dupuy, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Rhode Island Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000426417
NCT ID:
NCT00109876
Start Date:
September 2006
Completion Date:
Related Keywords:
- Lung Cancer
- stage I non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Medical City Dallas Hospital | Dallas, Texas 75230 |
| Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
| University of California Davis Cancer Center | Sacramento, California 95817 |
| Stony Brook University Cancer Center | Stony Brook, New York 11794-8174 |
| Rhode Island Hospital Comprehensive Cancer Center | Providence, Rhode Island 02903 |
| Providence Cancer Center at Sacred Heart Medical Center | Spokane, Washington 99220-2555 |
| William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
| Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
| Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
| Providence Cancer Center at Holy Family Hospital | Spokane, Washington 99207 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
| UAB Comprehensive Cancer Center | Birmingham, Alabama 35294 |
| Boston University Cancer Research Center | Boston, Massachusetts 02118 |
| Good Samaritan Hospital Cancer Treatment Center | Cincinnati, Ohio 45220 |
| H. Clay Evans Johnson Cancer Center at Memorial Hospital | Chattanooga, Tennessee 37404 |
