Lung Cancer
Conditions
Keywords
stage I non-small cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, large cell lung cancer, squamous cell lung cancer
Brief 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.
Detailed description
OBJECTIVES: Primary * To determine progession free survivial rates in patients with inoperable stage IA and select stage IB non-small cell lung cancer treated with external-beam radiation therapy and radiofrequency ablation (RFA). Secondary * To determine the acute and late toxicity of combining RFA with external-beam radiation therapy. * To determine the patterns of failure at time of first relapse. * To determine the rate of overall survival at 1 and 2 years after treatment. * To evaluate the ability of peak standard uptake value (SUV) and max SUV obtained prior to RFA to predict local control and time to progression. * To measure post RFA/simulation (treatment planning) PET max and peak SUV's and correlate this data with local control at 1 and 2 years. * To evaluate the ability of peak and max SUV's for fludeoxyglucose F 18 obtained shortly after radiotherapy (post-treatment) to predict local control and time to progression. * To evaluate PET-CT data and its utility in guiding radiation therapy treatment planning. * To explore the use of dual time point imaging PET data obtained to predict local control and also to differentiate between recurrence versus inflammation when applicable. * To assess physical function as a prognostic measure, and to determine the impact of treatment on physical function. * To evaluate the impact of treatment on generic and disease-specific quality of life. 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.
Interventions
PROCEDUREradiofrequency ablation
RADIATIONradiation therapy
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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: *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Two Year Progression Free Survival Rate | 2 years | the number of patients surviving progression-free at two years. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the Radiation Oncology Clinic at the Comprehensive Cancer Center of Wake Forest University.
Participants by arm
| Arm | Count |
|---|---|
| Radiofrequency Ablation Combined With External | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Radiofrequency Ablation Combined With External |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 70.5 years STANDARD_DEVIATION 9.7 |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 12 |
| serious Total, serious adverse events | 8 / 12 |
Outcome results
Primary
Two Year Progression Free Survival Rate
the number of patients surviving progression-free at two years.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiofrequency Ablation Combined With External | Two Year Progression Free Survival Rate | 8 participants |