Trial Outcomes & Findings for Radiofrequency Ablation in Treating Patients With Stage I Non-Small Cell Lung Cancer (NCT NCT00109876)

NCT ID: NCT00109876

Last Updated: 2017-03-08

Results Overview

Percentage of participants who were alive at 2 years. The 2 year survival was estimated using the Kaplan Meier method.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 54 participants
• Primary outcome timeframe: 2 years from registration
• Results posted on: 2017-03-08

Participant Flow

Fifty-four (54) participants were enrolled from 16 institutions from December 2006 to November 2010.

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.

Participant milestones

Measure	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.
Overall Study STARTED	51
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radiofrequency Ablation in Treating Patients With Stage I Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	RFA Therapy n=51 Participants 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.
Age, Continuous	76 years n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG)Performance Status 0 = Asymptomatic and fully active	9 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG)Performance Status 1= Symptomatic and fully ambulatory	29 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG)Performance Status 2= Symptomatic and ambulatory	13 Participants n=5 Participants
Baseline Forced Expiratory Volume in 1 second (FEV1)	48 Percentage of predicted n=5 Participants
Baseline diffusing capacity of the lung for carbon monoxide (DLCO)	42 Percentage of predicted n=5 Participants
Baseline forced vital capacity	2070 mL n=5 Participants

PRIMARY outcome

Timeframe: 2 years from registration

Population: All enrolled participants who met the eligibility criteria.

Percentage of participants who were alive at 2 years. The 2 year survival was estimated using the Kaplan Meier method.

Outcome measures

Measure	RFA Therapy n=51 Participants 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.
Overall Survival at 2 Years	69.8 percentage of participants Interval 58.0 to 83.9

SECONDARY outcome

Timeframe: Up to 2 years

Population: All enrolled participants who met the eligibility criteria.

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.

Outcome measures

Measure	RFA Therapy n=51 Participants 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.
Overall Time to Local Failure	NA years Interval 1.17 to The median of time to local failure and upper limit of 95% confidence interval are not attainable.

SECONDARY outcome

Timeframe: Up to 2 years

Population: All enrolled participants who met the eligibility criteria.

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.

Outcome measures

Measure	RFA Therapy n=51 Participants 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.
Overall Time to Recurrence	1.40 years Interval 0.75 to The upper limit of 95% confidence interval is not attainable.

SECONDARY outcome

Timeframe: Up to 2 years

Population: All enrolled participants who met the eligibility criteria.

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.

Outcome measures

Measure	RFA Therapy n=51 Participants 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.
Number of Procedures Deemed Technical Successes	50 number of technical successes

SECONDARY outcome

Timeframe: Up to 2 years

Population: All enrolled participants who met the eligibility criteria.

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.

Outcome measures

Measure	RFA Therapy n=51 Participants 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.
Incidence of Adverse Events Grade 0 Adverse Events	22 Participants
Incidence of Adverse Events Grade 1 Adverse Events	5 Participants
Incidence of Adverse Events Grade 2 Adverse Events	6 Participants
Incidence of Adverse Events Grade 3 Adverse Events	12 Participants
Incidence of Adverse Events Grade 4 Adverse Events	3 Participants
Incidence of Adverse Events Grade 5 Adverse Events	3 Participants

SECONDARY outcome

Timeframe: Baseline and Month 3

Population: All enrolled participants who met the eligibility criteria.

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.

Outcome measures

Measure	RFA Therapy n=51 Participants 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.
Change in Pulmonary Function From Baseline at Month 3 FEV1, % predicted · Missing	12 Participants
Change in Pulmonary Function From Baseline at Month 3 FEV1, % predicted · 10% increase	5 Participants
Change in Pulmonary Function From Baseline at Month 3 FEV1, % predicted · 10% decrease	3 Participants
Change in Pulmonary Function From Baseline at Month 3 FEV1, % predicted · Neither increase nor decrease of 10%	31 Participants
Change in Pulmonary Function From Baseline at Month 3 DLCO, % predicted · Missing	17 Participants
Change in Pulmonary Function From Baseline at Month 3 DLCO, % predicted · 10% increase	9 Participants
Change in Pulmonary Function From Baseline at Month 3 DLCO, % predicted · 10% decrease	4 Participants
Change in Pulmonary Function From Baseline at Month 3 DLCO, % predicted · Neither increase nor decrease of 10%	21 Participants

SECONDARY outcome

Timeframe: Baseline and Month 24

Population: All enrolled participants who met the eligibility criteria.

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.

Outcome measures

Measure	RFA Therapy n=51 Participants 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.
Change in Pulmonary Function From Baseline at Month 24 FEV1, % predicted · Missing	30 Participants
Change in Pulmonary Function From Baseline at Month 24 FEV1, % predicted · 10% increase	7 Participants
Change in Pulmonary Function From Baseline at Month 24 FEV1, % predicted · 10% decrease	4 Participants
Change in Pulmonary Function From Baseline at Month 24 FEV1, % predicted · Neither increase nor decrease of 10%	10 Participants
Change in Pulmonary Function From Baseline at Month 24 DLCO, % predicted · Missing	35 Participants
Change in Pulmonary Function From Baseline at Month 24 DLCO, % predicted · 10% increase	6 Participants
Change in Pulmonary Function From Baseline at Month 24 DLCO, % predicted · 10% decrease	4 Participants
Change in Pulmonary Function From Baseline at Month 24 DLCO, % predicted · Neither increase nor decrease of 10%	6 Participants

Adverse Events

RFA Therapy

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	RFA Therapy n=51 participants at risk 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.
Cardiac disorders Myocardial ischemia	2.0% 1/51 • Number of events 1 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Gastrointestinal disorders Diarrhea	2.0% 1/51 • Number of events 1 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Gastrointestinal disorders Stomach pain	2.0% 1/51 • Number of events 1 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Gastrointestinal disorders Vomiting	2.0% 1/51 • Number of events 1 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
General disorders Death	2.0% 1/51 • Number of events 1 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
General disorders Fever	2.0% 1/51 • Number of events 1 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
General disorders Sudden death	2.0% 1/51 • Number of events 1 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Infections and infestations Colitis, infectious (e.g., Clostridium difficile)	2.0% 1/51 • Number of events 1 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Infections and infestations Esophageal infection	2.0% 1/51 • Number of events 1 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Infections and infestations Infection	2.0% 1/51 • Number of events 1 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Infections and infestations Joint infection	2.0% 1/51 • Number of events 1 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Infections and infestations Pleural infection	2.0% 1/51 • Number of events 1 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Infections and infestations Pneumonia	2.0% 1/51 • Number of events 1 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Infections and infestations Urinary tract infection	2.0% 1/51 • Number of events 1 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Injury, poisoning and procedural complications Postoperative thoracic procedure complication	7.8% 4/51 • Number of events 4 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Investigations Cardiac troponin I increased	2.0% 1/51 • Number of events 1 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Investigations INR increased	2.0% 1/51 • Number of events 1 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Metabolism and nutrition disorders Hypoglycemia	2.0% 1/51 • Number of events 1 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders Myositis	2.0% 1/51 • Number of events 1 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Renal and urinary disorders Renal failure	2.0% 1/51 • Number of events 1 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Renal and urinary disorders Urogenital disorder	2.0% 1/51 • Number of events 1 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	2.0% 1/51 • Number of events 1 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	5.9% 3/51 • Number of events 3 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Bronchospasm	2.0% 1/51 • Number of events 1 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Dyspnea	13.7% 7/51 • Number of events 8 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Hypoxia	7.8% 4/51 • Number of events 4 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.9% 2/51 • Number of events 2 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.9% 3/51 • Number of events 3 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Pneumothorax	27.5% 14/51 • Number of events 15 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	5.9% 3/51 • Number of events 4 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.
Vascular disorders Hypotension	2.0% 1/51 • Number of events 1 • 2 years Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 3.0.

Additional Information

Damian E. Dupuy, MD

Rhode Island Hospital/Alpert Medical School

Phone: 401 - 444 - 5184

Email: ddupuy@lifespan.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60