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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

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 HospitalDallas, Texas  75230
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
University of California Davis Cancer CenterSacramento, California  95817
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
Rhode Island Hospital Comprehensive Cancer CenterProvidence, Rhode Island  02903
Providence Cancer Center at Sacred Heart Medical CenterSpokane, Washington  99220-2555
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence Cancer Center at Holy Family HospitalSpokane, Washington  99207
Massachusetts General HospitalBoston, Massachusetts  02114-2617
UAB Comprehensive Cancer CenterBirmingham, Alabama  35294
Boston University Cancer Research CenterBoston, Massachusetts  02118
Good Samaritan Hospital Cancer Treatment CenterCincinnati, Ohio  45220
H. Clay Evans Johnson Cancer Center at Memorial HospitalChattanooga, Tennessee  37404