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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00109876
First received: May 3, 2005
Last updated: July 23, 2015
Last verified: July 2015

May 3, 2005
July 23, 2015
September 2006
July 2010   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: 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 [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Overall time to recurrence [ Time Frame: assessed up to 2 years ] [ Designated as safety issue: No ]
  • Proportion of technical success assessed by captured images from the treatment CT showing RFA electrode placement and the recorded RFA generator parameters (e.g., impedance, current, power, treatment time and maximum intra-tumoral temperature) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Incidence of adverse events using the Common Terminology Criteria for Adverse Events version 3.0 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
  • Change in pulmonary function [ Time Frame: Baseline to up to 2 years ] [ Designated as safety issue: No ]
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

This pilot clinical trial studies how well radiofrequency ablation works in treating patients with stage IA non-small cell lung cancer. Radiofrequency ablation uses high-frequency electric current to kill tumor cells. Computed tomography (CT)-guided radiofrequency ablation may be a better treatment for non-small cell lung cancer.

PRIMARY OBJECTIVES:

I. To assess the overall 2-year survival rate after radiofrequency ablation (RFA).

SECONDARY OBJECTIVES:

I. To assess freedom from regional or distant recurrence. II. To assess freedom from local recurrence in the ablated lobe. III. To estimate the number of procedures deemed technical successes. IV. To evaluate procedure-specific morbidity and mortality. V. To explore the utility of immediate (within 96 hours) post-RFA positron emission tomography (PET) in predicting overall survival and local control.

VI. To explore the effect of RFA on both short-term (3 months post-RFA) and long-term (24 months post-RFA) pulmonary function.

OUTLINE:

A radiofrequency electrode is placed by CT guidance into the target tumor. Patients undergo RFA directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° Celsius (C). Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.

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

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
Procedure: Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation
Undergo RFA
Other Name: CT-guided optical sensor-guided radiofrequency ablation, CT-guided optical sensor-guided RF ablation
Experimental: Treatment (RFA therapy)
A radiofrequency electrode is placed by CT guidance into the target tumor. Patients undergo 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.
Intervention: Procedure: Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation
Not Provided

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

Inclusion Criteria:

  • PRE-REGISTRATION CRITERIA:
  • Patients must have a lung nodule suspicious for clinical stage I non-small cell lung cancer (NSCLC)
  • Patient must have a mass =< 3 cm maximum diameter by CT size estimate: clinical stage IA
  • Patient must have been evaluated by a thoracic surgeon and been deemed at high risk for a lung resection; NOTE: if the evaluating surgeon is not a member of American College of Surgeons Oncology Group (ACOSOG), then an ACOSOG thoracic surgeon must confirm with dated signature that the patient is high-risk and appropriate for RFA
  • Patient must have fludeoxyglucose F 18 (FDG)-PET and a CT scan of the chest with upper abdomen within 60 days prior to pre-registration; patient must have pulmonary function tests (PFTs) within 120 days prior to registration
  • Patient must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0, 1, or 2
  • Patient must meet at least one major criterion or meet a minimum of two minor criteria as described below:

    • Major criteria

      • Forced expiratory volume in one second (FEV1) =< 50% predicted
      • Diffusing capacity of the lung for carbon monoxide (DLCO) =< 50% predicted
    • Minor Criteria

      • Age >= 75
      • FEV1 51-60% predicted
      • DLCO 51-60% predicted
      • Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mmHg) as estimated by echocardiography or right heart catheterization
      • Poor left ventricular function (defined as an ejection fraction of 40% or less)
      • Resting or exercise arterial partial pressure of oxygen (pO2) =< 55 mmHg or oxygen saturation (SpO2) =< 88%
      • Partial pressure of carbon dioxide (pCO2) > 45 mmHg
      • Modified Medical Research Council (MMRC) Dyspnea Scale >= 3
  • Patient must not have had previous intra-thoracic radiation therapy
  • Women of child-bearing potential must have negative serum or urine pregnancy test within 2 weeks of registration
  • REGISTRATION ACTIVATION CRITERIA:
  • Patient must have histologically or cytologically proven NSCLC, 3 cm or smaller, as determined by the largest dimension on CT lung windows
  • Patient's tumor must be non-contiguous with vital structures: trachea, esophagus, aorta, aortic arch branches and heart and lesions must be accessible via percutaneous transthoracic route
  • Patient must have all suspicious mediastinal lymph nodes (> 1 cm short-axis dimension on CT scan or positive on PET scan) assessed by the following to confirm negative involvement with NSCLC (mediastinoscopy, endo-esophageal ultrasound-guided needle aspiration, CT-guided, video-assisted thoracoscopic or open lymph node biopsy)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00109876
ACOSOG-Z4033, ACOSOG-Z4033, CDR0000426417
Yes
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Damian E. Dupuy, MD Rhode Island Hospital
Alliance for Clinical Trials in Oncology
July 2015

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