An interventional study of radiofrequency ablation and radiation therapy in Lung Cancer, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2019-05-08.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
RATIONALE: Radiofrequency ablation uses a high-frequency electric current to kill tumor cells. External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiofrequency ablation together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving radiofrequency ablation together with external-beam radiation therapy works in treating patients with stage I non-small cell lung cancer that cannot be removed by surgery.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients undergo fludeoxyglucose F18 positron emission tomography (FDG-PET) and CT scan at baseline. Patients then undergo radiofrequency ablation (RFA). Beginning within 5 weeks after completion of RFA, patients undergo external-beam radiation therapy once daily, 5 days a week, for 5-6 weeks. FDG-PET/CT scan is repeated 3-4 weeks after RFA and 12-16 weeks after completion of external-beam radiation therapy.
Quality of life is assessed at baseline, during treatment, and at 16 weeks and at 1 year after completion of treatment.
After completion of study treatment, patients are followed periodically for 2 years.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 13 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
Node-negative patients will have hilar or mediastinal lymph nodes ≤ 1.5 cm and no clinically suspicious uptake on fludeoxyglucose F 18 (FDG)-PET in those areas
Any patient with suspected M1 disease based on pre-treatment PET-CT imaging should have biopsy if possible
PATIENT CHARACTERISTICS:
Inclusion Criteria:
Exclusion Criteria:
PRIOR CONCURRENT THERAPY:
Exclusion Criteria:
Patients must not receive other concurrent anticancer therapies while on protocol including any of the following:
Surgery
Radiofrequency Ablation (RFA)under computerized tomography guidance followed 3-4 weeks later with External Beam Radiation Therapy
Procedure: radiofrequency ablation · Radiation: radiation therapy
Two Year Progression Free Survival Rate
the number of patients surviving progression-free at two years.
Time frame: 2 years
Participants were recruited from the Radiation Oncology Clinic at the Comprehensive Cancer Center of Wake Forest University.
| Milestone | Radiofrequency Ablation Combined With External |
|---|---|
| Started | 13 |
| Completed | 13 |
| Not completed | 0 |
the number of patients surviving progression-free at two years.
| participants | Radiofrequency Ablation Combined With External |
|---|---|
| Two Year Progression Free Survival Rate | 8 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Radiofrequency Ablation Combined With External | — | 8/12 (66.7%) | 12/12 (100%) |
| Event | Radiofrequency Ablation Combined With External |
|---|---|
| Carbon monoxide diffusionInvestigations | 4/12 |
| LymphopeniaInvestigations | 4/12 |
| decreased forced expiratory volumeRespiratory, thoracic and mediastinal disorders | 3/12 |
| hyperglycemiaInvestigations | 2/12 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 1/12 |
| Lung infectionInfections and infestations | 1/12 |
| BurnGeneral disorders | 1/12 |
| Event | Radiofrequency Ablation Combined With External |
|---|---|
| decreased forced expiratory volumeRespiratory, thoracic and mediastinal disorders | 9/12 |
| Low HemoglobinInvestigations | 8/12 |
| Carbon monoxide diffusionInvestigations | 8/12 |
| hyperglycemiaInvestigations | 8/12 |
| CoughRespiratory, thoracic and mediastinal disorders | 6/12 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 6/12 |
| FatigueGeneral disorders | 5/12 |
| Pain: Chest wallGeneral disorders | 5/12 |
| DyspneaReproductive system and breast disorders | 4/12 |
| Pneumonitis/pulmonary infiltratesRespiratory, thoracic and mediastinal disorders | 4/12 |
| Age, Categorical(Participants) | Radiofrequency Ablation Combined With External |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 4 |
| >=65 years | 9 |
| Age, Continuous(years) | Radiofrequency Ablation Combined With External |
|---|---|
| Mean | 70.5 ± 9.7 |
| Sex: Female, Male(Participants) | Radiofrequency Ablation Combined With External |
|---|---|
| Female | 4 |
| Male | 9 |
| Region of Enrollment(participants) | Radiofrequency Ablation Combined With External |
|---|---|
| United States | 13 |
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences