N/A
N=51
Radiofrequency Ablation in Treating Patients With Stage I Non-Small Cell Lung Cancer
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00109876 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Overall Survival at 2 Years — 69.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival at 2 Years |
69.8 | — |
| SECONDARY Overall Time to Local Failure |
NA | — |
| SECONDARY Overall Time to Recurrence |
1.40 | — |
| SECONDARY Number of Procedures Deemed Technical Successes |
50 | — |
| SECONDARY Incidence of Adverse Events |
22; 5; 6; 12; 3; 3 | — |
| SECONDARY Change in Pulmonary Function From Baseline at Month 3 |
12; 5; 3; 31; 17; 9 | — |
| SECONDARY Change in Pulmonary Function From Baseline at Month 24 |
30; 7; 4; 10; 35; 6 | — |
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.
Eligibility Criteria
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 = = 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) = 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)
Data sourced from ClinicalTrials.gov (NCT00109876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.