NCT00109876

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation	Undergo RFA

Timeline

• Start date: 2006-09-01
• Primary completion: 2012-08-01
• Completion: 2013-02-01
• First posted: 2005-05-04
• Last updated: 2017-03-08
• Results posted: 2017-01-24

Locations

17 sites across 1 country: United States