Lung Cancer
Conditions
Keywords
stage I non-small cell lung cancer
Brief summary
This pilot clinical trial studies how well radiofrequency ablation works in treating patients with stage IA non-small cell lung cancer. Radiofrequency ablation uses high-frequency electric current to kill tumor cells. Computed tomography (CT)-guided radiofrequency ablation may be a better treatment for non-small cell lung cancer.
Detailed description
PRIMARY OBJECTIVES: I. To assess the overall 2-year survival rate after radiofrequency ablation (RFA). SECONDARY OBJECTIVES: I. To assess freedom from regional or distant recurrence. II. To assess freedom from local recurrence in the ablated lobe. III. To estimate the number of procedures deemed technical successes. IV. To evaluate procedure-specific morbidity and mortality. V. To explore the utility of immediate (within 96 hours) post-RFA positron emission tomography (PET) in predicting overall survival and local control. VI. To explore the effect of RFA on both short-term (3 months post-RFA) and long-term (24 months post-RFA) pulmonary function. OUTLINE: A radiofrequency electrode is placed by CT guidance into the target tumor. Patients undergo RFA directly to the tumor for up to 12 minutes to obtain an intratumoral temperature \> 60° Celsius (C). Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 1 year.
Interventions
PROCEDUREComputed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation
Undergo RFA
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* PRE-REGISTRATION CRITERIA: * Patients must have a lung nodule suspicious for clinical stage I non-small cell lung cancer (NSCLC) * Patient must have a mass =\< 3 cm maximum diameter by CT size estimate: clinical stage IA * Patient must have been evaluated by a thoracic surgeon and been deemed at high risk for a lung resection; NOTE: if the evaluating surgeon is not a member of American College of Surgeons Oncology Group (ACOSOG), then an ACOSOG thoracic surgeon must confirm with dated signature that the patient is high-risk and appropriate for RFA * Patient must have fludeoxyglucose F 18 (FDG)-PET and a CT scan of the chest with upper abdomen within 60 days prior to pre-registration; patient must have pulmonary function tests (PFTs) within 120 days prior to registration * Patient must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0, 1, or 2 * Patient must meet at least one major criterion or meet a minimum of two minor criteria as described below: * Major criteria * Forced expiratory volume in one second (FEV1) =\< 50% predicted * Diffusing capacity of the lung for carbon monoxide (DLCO) =\< 50% predicted * Minor Criteria * Age \>= 75 * FEV1 51-60% predicted * DLCO 51-60% predicted * Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mmHg) as estimated by echocardiography or right heart catheterization * Poor left ventricular function (defined as an ejection fraction of 40% or less) * Resting or exercise arterial partial pressure of oxygen (pO2) =\< 55 mmHg or oxygen saturation (SpO2) =\< 88% * Partial pressure of carbon dioxide (pCO2) \> 45 mmHg * Modified Medical Research Council (MMRC) Dyspnea Scale \>= 3 * Patient must not have had previous intra-thoracic radiation therapy * Women of child-bearing potential must have negative serum or urine pregnancy test within 2 weeks of registration * REGISTRATION ACTIVATION CRITERIA: * Patient must have histologically or cytologically proven NSCLC, 3 cm or smaller, as determined by the largest dimension on CT lung windows * Patient's tumor must be non-contiguous with vital structures: trachea, esophagus, aorta, aortic arch branches and heart and lesions must be accessible via percutaneous transthoracic route * Patient must have all suspicious mediastinal lymph nodes (\> 1 cm short-axis dimension on CT scan or positive on PET scan) assessed by the following to confirm negative involvement with NSCLC (mediastinoscopy, endo-esophageal ultrasound-guided needle aspiration, CT-guided, video-assisted thoracoscopic or open lymph node biopsy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival at 2 Years | 2 years from registration | Percentage of participants who were alive at 2 years. The 2 year survival was estimated using the Kaplan Meier method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Time to Local Failure | Up to 2 years | The overall time to local failure was defined as the time from registration to documentation of \> local failure. The local failure was defined as the recurrence in the same lobe or hilum (N1 nodes) or progression at the ablated site after treatment affects have subsided. |
| Overall Time to Recurrence | Up to 2 years | The overall time to recurrence was defined as the time from registration to documentation of disease recurrence. If a patient dies without a documentation of disease recurrence, the patient will be considered to have had tumor recurrence at the time of their death unless there is sufficient evidence to conclude no recurrence occurred prior to death. |
| Number of Procedures Deemed Technical Successes | Up to 2 years | The number of procedures deemed technical successes is defined as the number of patients with a RFA procedures deemed a technical success. A technical success is defined as follows: The pertinent captured images from the treatment CT showing RFA electrode placement and the recorded RFA generator parameters (e.g. impedance, current, power, treatment time and maximum intra-tumoral temperature) were reviewed by the quality control panel to determine technical success. |
| Incidence of Adverse Events | Up to 2 years | The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 was used to evaluate adverse event.\> Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death. |
| Change in Pulmonary Function From Baseline at Month 3 | Baseline and Month 3 | Pulmonary function test values include forced expiratory volume 1 (FEV1) and carbon monoxide diffusion (DLCO). The distribution of clinically meaningful changes (10% increase or 10% decrease) in pulmonary function from the baseline to 3 was summarized. |
| Change in Pulmonary Function From Baseline at Month 24 | Baseline and Month 24 | Pulmonary function test values include forced expiratory volume 1 (FEV1) and carbon monoxide diffusion (DLCO). The distribution of clinically meaningful changes (10% increase or 10% decrease) in pulmonary function from the baseline to 24 was summarized. |
Countries
United States
Participant flow
Recruitment details
Fifty-four (54) participants were enrolled from 16 institutions from December 2006 to November 2010.
Pre-assignment details
Two participants had pre-RFA positron emission tomography (PET) not within 60 days before study preregistration and one participant did not had non-small cell lung cancer, which were deemed ineligible for the studies, and were excluded from all analyses.
Participants by arm
| Arm | Count |
|---|---|
| RFA Therapy Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature \> 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature. | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | RFA Therapy |
|---|---|
| Age, Continuous | 76 years |
| Baseline diffusing capacity of the lung for carbon monoxide (DLCO) | 42 Percentage of predicted |
| Baseline Forced Expiratory Volume in 1 second (FEV1) | 48 Percentage of predicted |
| Baseline forced vital capacity | 2070 mL |
| Eastern Cooperative Oncology Group (ECOG)Performance Status 0 = Asymptomatic and fully active | 9 Participants |
| Eastern Cooperative Oncology Group (ECOG)Performance Status 1= Symptomatic and fully ambulatory | 29 Participants |
| Eastern Cooperative Oncology Group (ECOG)Performance Status 2= Symptomatic and ambulatory | 13 Participants |
| Region of Enrollment United States | 51 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 29 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
Primary
Overall Survival at 2 Years
Percentage of participants who were alive at 2 years. The 2 year survival was estimated using the Kaplan Meier method.
Time frame: 2 years from registration
Population: All enrolled participants who met the eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RFA Therapy | Overall Survival at 2 Years | 69.8 percentage of participants |
Secondary
Change in Pulmonary Function From Baseline at Month 24
Pulmonary function test values include forced expiratory volume 1 (FEV1) and carbon monoxide diffusion (DLCO). The distribution of clinically meaningful changes (10% increase or 10% decrease) in pulmonary function from the baseline to 24 was summarized.
Time frame: Baseline and Month 24
Population: All enrolled participants who met the eligibility criteria.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| RFA Therapy | Change in Pulmonary Function From Baseline at Month 24 | FEV1, % predicted | Missing | 30 Participants |
| RFA Therapy | Change in Pulmonary Function From Baseline at Month 24 | FEV1, % predicted | 10% increase | 7 Participants |
| RFA Therapy | Change in Pulmonary Function From Baseline at Month 24 | FEV1, % predicted | 10% decrease | 4 Participants |
| RFA Therapy | Change in Pulmonary Function From Baseline at Month 24 | FEV1, % predicted | Neither increase nor decrease of 10% | 10 Participants |
| RFA Therapy | Change in Pulmonary Function From Baseline at Month 24 | DLCO, % predicted | Missing | 35 Participants |
| RFA Therapy | Change in Pulmonary Function From Baseline at Month 24 | DLCO, % predicted | 10% increase | 6 Participants |
| RFA Therapy | Change in Pulmonary Function From Baseline at Month 24 | DLCO, % predicted | 10% decrease | 4 Participants |
| RFA Therapy | Change in Pulmonary Function From Baseline at Month 24 | DLCO, % predicted | Neither increase nor decrease of 10% | 6 Participants |
Secondary
Change in Pulmonary Function From Baseline at Month 3
Pulmonary function test values include forced expiratory volume 1 (FEV1) and carbon monoxide diffusion (DLCO). The distribution of clinically meaningful changes (10% increase or 10% decrease) in pulmonary function from the baseline to 3 was summarized.
Time frame: Baseline and Month 3
Population: All enrolled participants who met the eligibility criteria.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| RFA Therapy | Change in Pulmonary Function From Baseline at Month 3 | FEV1, % predicted | Missing | 12 Participants |
| RFA Therapy | Change in Pulmonary Function From Baseline at Month 3 | FEV1, % predicted | 10% increase | 5 Participants |
| RFA Therapy | Change in Pulmonary Function From Baseline at Month 3 | FEV1, % predicted | 10% decrease | 3 Participants |
| RFA Therapy | Change in Pulmonary Function From Baseline at Month 3 | FEV1, % predicted | Neither increase nor decrease of 10% | 31 Participants |
| RFA Therapy | Change in Pulmonary Function From Baseline at Month 3 | DLCO, % predicted | Missing | 17 Participants |
| RFA Therapy | Change in Pulmonary Function From Baseline at Month 3 | DLCO, % predicted | 10% increase | 9 Participants |
| RFA Therapy | Change in Pulmonary Function From Baseline at Month 3 | DLCO, % predicted | 10% decrease | 4 Participants |
| RFA Therapy | Change in Pulmonary Function From Baseline at Month 3 | DLCO, % predicted | Neither increase nor decrease of 10% | 21 Participants |
Secondary
Incidence of Adverse Events
The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 was used to evaluate adverse event.\> Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.
Time frame: Up to 2 years
Population: All enrolled participants who met the eligibility criteria.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RFA Therapy | Incidence of Adverse Events | Grade 0 Adverse Events | 22 Participants |
| RFA Therapy | Incidence of Adverse Events | Grade 1 Adverse Events | 5 Participants |
| RFA Therapy | Incidence of Adverse Events | Grade 2 Adverse Events | 6 Participants |
| RFA Therapy | Incidence of Adverse Events | Grade 3 Adverse Events | 12 Participants |
| RFA Therapy | Incidence of Adverse Events | Grade 4 Adverse Events | 3 Participants |
| RFA Therapy | Incidence of Adverse Events | Grade 5 Adverse Events | 3 Participants |
Secondary
Number of Procedures Deemed Technical Successes
The number of procedures deemed technical successes is defined as the number of patients with a RFA procedures deemed a technical success. A technical success is defined as follows: The pertinent captured images from the treatment CT showing RFA electrode placement and the recorded RFA generator parameters (e.g. impedance, current, power, treatment time and maximum intra-tumoral temperature) were reviewed by the quality control panel to determine technical success.
Time frame: Up to 2 years
Population: All enrolled participants who met the eligibility criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RFA Therapy | Number of Procedures Deemed Technical Successes | 50 number of technical successes |
Secondary
Overall Time to Local Failure
The overall time to local failure was defined as the time from registration to documentation of \> local failure. The local failure was defined as the recurrence in the same lobe or hilum (N1 nodes) or progression at the ablated site after treatment affects have subsided.
Time frame: Up to 2 years
Population: All enrolled participants who met the eligibility criteria.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RFA Therapy | Overall Time to Local Failure | NA years |
Secondary
Overall Time to Recurrence
The overall time to recurrence was defined as the time from registration to documentation of disease recurrence. If a patient dies without a documentation of disease recurrence, the patient will be considered to have had tumor recurrence at the time of their death unless there is sufficient evidence to conclude no recurrence occurred prior to death.
Time frame: Up to 2 years
Population: All enrolled participants who met the eligibility criteria.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RFA Therapy | Overall Time to Recurrence | 1.40 years |