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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00109876
First received: May 3, 2005
Last updated: June 6, 2012
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Procedure: radiofrequency ablation
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Pilot Study of Radiofrequency Ablation in High-Risk Patients With Stage IA Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival at 2 years [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall time to local failure [ Designated as safety issue: No ]
  • Overall time to recurrence [ Designated as safety issue: No ]
  • Proportion of technical success [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]

Estimated Enrollment: 55
Study Start Date: September 2006
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109876

Locations
United States, Alabama
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
University of California Davis Cancer Center
Sacramento, California, United States, 95817
United States, Massachusetts
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
United States, New York
Stony Brook University Cancer Center
Stony Brook, New York, United States, 11794-9446
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
United States, Ohio
Good Samaritan Hospital Cancer Treatment Center
Cincinnati, Ohio, United States, 45220
United States, Oregon
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
United States, Rhode Island
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States, 02903
United States, Tennessee
H. Clay Evans Johnson Cancer Center at Memorial Hospital
Chattanooga, Tennessee, United States, 37404
United States, Texas
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
United States, Utah
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
United States, Washington
Providence Cancer Center at Holy Family Hospital
Spokane, Washington, United States, 99207
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, United States, 99204
United States, Wisconsin
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
American College of Surgeons
Investigators
Study Chair: Damian E. Dupuy, MD Rhode Island Hospital
Investigator: Kamran Ahrar, MD M.D. Anderson Cancer Center
Investigator: Robert D. Suh, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: David M. Ota, American College of Surgeons Oncology Group
ClinicalTrials.gov Identifier: NCT00109876     History of Changes
Other Study ID Numbers: CDR0000426417, ACOSOG-Z4033
Study First Received: May 3, 2005
Last Updated: June 6, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014