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

May 3, 2005
June 6, 2012
September 2006
July 2010   (final data collection date for primary outcome measure)
Overall survival at 2 years [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00109876 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Radiofrequency Ablation in Treating Patients With Stage I Non-Small Cell Lung Cancer
A Pilot Study of Radiofrequency Ablation in High-Risk Patients With Stage IA Non-Small Cell Lung Cancer

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Lung Cancer
Procedure: radiofrequency ablation
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
Not Provided
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00109876
CDR0000426417, ACOSOG-Z4033
Not Provided
David M. Ota, American College of Surgeons Oncology Group
American College of Surgeons
National Cancer Institute (NCI)
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
National Cancer Institute (NCI)
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP