Clinical trial · Interventional
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
NCT00109876CI-TRIAL-00026341completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (RFA therapy)
- description
- 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.
- interventionNames
- Procedure: Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation
Primary outcomes (1)
- measure
- Overall Survival at 2 Years
- timeFrame
- 2 years from registration
- description
- Percentage of participants who were alive at 2 years. The 2 year survival was estimated using the Kaplan Meier method.
Secondary outcomes (6)
- measure
- Overall Time to Local Failure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)References
Publications (0)
Data not yet available
No reference posted for this study.