Radiofrequency Ablation and External-Beam Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
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.
Checked against the public recordLast updated May 8, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Wake Forest University Health Sciences
- Interventions being studied
- Procedure: radiofrequency ablation; Radiation: radiation therapy
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer * Cytology or biopsy-proven disease * Stage IA (T1N0M0) or select stage IB (T2N0M0 because of visceral pleural involvement or size ≥ 3.0 cm) * Tumor size ≤ 3.5 cm * 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 * Patients with \> 1.5 cm lymph nodes and clinically suspicious FDG-PET uptake will still be eligible if directed tissue biopsy or needle aspiration of abnormally identified area are negative for cancer * Patients with \> 1.5 cm and \< 2.0 cm lymph nodes and no clinically suspicious FDG-PET uptake in those areas will still be eligible * 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 * If the biopsy is positive, the patient should be treated as per the clinician's preference off of this protocol * If the biopsy is negative and representative of the lesion in question then the patient may be treated as per this protocol * If the biopsy is non-diagnostic, consideration should be given to repeat biopsy * If the repeat biopsy remains non-diagnostic or a biopsy is not feasible than the patient will not be eligible for this protocol and should be treated per the clinician's preference PATIENT CHARACTERISTICS: * Inclusion Criteria: * ECOG performance status 0-2 * Women of childbearing potential must have a negative pregnancy test * Fertile women must use effective contraception * Exclusion Criteria: * History of prior malignancy within the past 2 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, T1N0 squamous cell carcinoma of the larynx, or localized prostate cancer with a current PSA level \< 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to study entry * Pregnant or lactating women 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 * Surgical treatment of nonmelanomatous skin cancer or ≤ T1 urothelial cell carcinoma allowed
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 8, 2019. Always confirm current availability with the study team.