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| ID | Type | Description | Link |
|---|---|---|---|
| CCCWFU 62306 | Other Identifier | CCCWFU | |
| IRB00001334 | Other Identifier | WFUHS IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency Ablation with External Beam Radiation | Experimental | Radiofrequency Ablation (RFA)under computerized tomography guidance followed 3-4 weeks later with External Beam Radiation Therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiofrequency ablation | Procedure |
| ||
| radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Two Year Progression Free Survival Rate | the number of patients surviving progression-free at two years. | 2 years |
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DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
No bronchioloalveolar carcinoma
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
All patients are required to have been evaluated by a thoracic surgeon and have either refused surgery or been deemed medically inoperable due to comorbid conditions
CT images of the chest must be reviewed by an experienced interventional radiologist and the target lesion must be determined to be in a location where radiofrequency ablation is technically achievable based on the proximity of adjacent organs and structures
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:
Previous chest radiation to the lung or mediastinum
Patients must not receive other concurrent anticancer therapies while on protocol including any of the following:
Radiotherapy
Radiofrequency ablation
Other antineoplastic interventional radiology techniques
Chemotherapy
Biological therapy
Vaccine therapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| William Blackstock, MD | Wake Forest University Health Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
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Participants were recruited from the Radiation Oncology Clinic at the Comprehensive Cancer Center of Wake Forest University.
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiofrequency Ablation Combined With External |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Radiation |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiofrequency Ablation Combined With External |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Two Year Progression Free Survival Rate | the number of patients surviving progression-free at two years. | Posted | Number | participants | 2 years |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Radiofrequency Ablation Combined With External | 8 | 12 | 12 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Carbon monoxide diffusion | Investigations | Systematic Assessment |
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| hyperglycemia | Investigations | Systematic Assessment |
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| decreased forced expiratory volume | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Lymphopenia | Investigations | Systematic Assessment |
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| Lung infection | Infections and infestations | Systematic Assessment |
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| Burn | General disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low WBC | Investigations | Systematic Assessment |
| ||
| low Platelets | Investigations | Systematic Assessment |
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| Low Hemoglobin | Investigations | Systematic Assessment |
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| Hemorrhage/Bleeding - Other | Vascular disorders | Systematic Assessment |
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| Anorexia | General disorders | Systematic Assessment |
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| Alkaline phosphatase | Investigations | Systematic Assessment |
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| Urinary retention (including neurogenic bladder) | General disorders | Systematic Assessment |
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| Dyspnea | Reproductive system and breast disorders | Systematic Assessment |
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| Carbon monoxide diffusion | Investigations | Systematic Assessment |
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| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypertension | General disorders | Systematic Assessment |
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| Neuropathy: motor | Nervous system disorders | Systematic Assessment |
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| Low ANC | Investigations | Systematic Assessment |
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| Insomnia | General disorders | Systematic Assessment |
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| Rigors/chills | General disorders | Systematic Assessment |
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| Sweating | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| hyperglycemia | Investigations | Systematic Assessment |
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| hypoglycemia | Investigations | Systematic Assessment |
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| hypocalcemia | Investigations | Systematic Assessment |
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| hypomagnesemia | Investigations | Systematic Assessment |
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| hyponatremia | Investigations | Systematic Assessment |
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| hypokalemia | Investigations | Systematic Assessment |
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| hypoalbuminemia | Investigations | Systematic Assessment |
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| hyperbilirubinemia | Investigations | Systematic Assessment |
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| serum glutamic oxaloacetic transaminase | Investigations | Systematic Assessment |
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| hypernatremia | Investigations | Systematic Assessment |
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| Phlebitis | Vascular disorders | Systematic Assessment |
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| Ocular/Visual - Other | Eye disorders | Systematic Assessment |
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| Dysphagia | General disorders | Systematic Assessment |
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| Fever without neutropenia | General disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Edema: limb | Vascular disorders | Systematic Assessment |
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| Heartburn/dyspepsia | General disorders | Systematic Assessment |
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| Hypoxia | Investigations | Systematic Assessment |
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| Rash/desquamation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Partial Thromboplastin Time | Investigations | Systematic Assessment |
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| Ataxia | General disorders | Systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pain: Back | General disorders | Systematic Assessment |
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| Amylase | Investigations | Systematic Assessment |
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| "Fistula, pulmonary/upper respiratory: Bronchus" | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Bronchospasm wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pain: Chest/thorax | General disorders | Systematic Assessment |
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| Pain: Chest wall | General disorders | Systematic Assessment |
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| decreased forced expiratory volume | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| hypertriglyceridemia | Investigations | Systematic Assessment |
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| Injection site reaction | Immune system disorders | Systematic Assessment |
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| Lymphopenia | Investigations | Systematic Assessment |
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| Memory impairment | General disorders | Systematic Assessment |
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| Pain: Muscle | General disorders | Systematic Assessment |
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| Nail changes | General disorders | Systematic Assessment |
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| Ulcer Esophagus | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Esophagitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hemorrhage Lung | Vascular disorders | Systematic Assessment |
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| Soft tissue necrosis Thorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Vital capacity | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Infection with unknown ANC Lung (pneumonia) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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adverse events were tracked in two cycles, one during treatment and one longer term
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James Urbanic | Comprehensive Cancer Center of Wake Forest University | 336-713-3600 | jurbanic@wakehealth.edu |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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