N/A
N=13
Radiofrequency Ablation and External-Beam Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00499447 ↗Enrolled (actual)
13
Serious AEs
66.7%
Results posted
Mar 2013
Primary outcome: Primary: Two Year Progression Free Survival Rate — 8 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- radiofrequency ablation (Procedure); radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Two Year Progression Free Survival Rate |
8 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00499447). 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.