Lung CancerNCT00109876

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

A study testing Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer
What is being tested?: Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 17 sitesUnited States
Study dates: Sep 2006to Feb 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 25Show fewer

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)

Who cannot join

None listed.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

UAB Comprehensive Cancer Center
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston University Cancer Research Center
Boston, Massachusetts, 02118
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
H. Clay Evans Johnson Cancer Center at Memorial Hospital
Chattanooga, Tennessee, 37404
Good Samaritan Hospital Cancer Treatment Center
Cincinnati, Ohio, 45220
Medical City Dallas Hospital
Dallas, Texas, 75230
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, 97213-2967
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, 02903
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, 48073
University of California Davis Cancer Center
Sacramento, California, 95817
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, 99204
Providence Cancer Center at Holy Family Hospital
Spokane, Washington, 99207
Stony Brook University Cancer Center
Stony Brook, New York, 11794-9446

Other trials in United States

About this study

Official title: A Pilot Study of Radiofrequency Ablation in High-Risk Patients With Stage IA Non-Small Cell Lung Cancer

Read the detailed description

PRIMARY OBJECTIVES:

To assess the overall 2-year survival rate after radiofrequency ablation (RFA).

SECONDARY OBJECTIVES:

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.

Conditions: Lung Cancer
Being tested: Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation
Keywords: stage I non-small cell lung cancer
Medical subject headings: Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Computed Tomography-Guided Optical Sensor-Guided Radiofrequency AblationProcedure or surgery
Also called CT-guided optical sensor-guided radiofrequency ablation, CT-guided optical sensor-guided RF ablation
Undergo RFA

Study groups in NCT00109876
Study group	Role	What they receive
Treatment (RFA therapy)	Experimental	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° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature. Receives: Procedure: Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2 years from registration

Secondary outcomes (6)

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.
Measured: Up to 2 years
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.
Measured: Up to 2 years
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.
Measured: Up to 2 years
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.
Measured: Up to 2 years
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.
Measured: Baseline and Month 3
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.
Measured: Baseline and Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2006Feb 2013

First posted4 May 2005 (estimated)
Study startSep 2006
Primary completionAug 2012
Study completionFeb 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lung CancerStudies of the same condition, open and under way.
More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00109876
Sponsor's protocol ID: ACOSOG-Z4033
Other IDs: ACOSOG-Z4033, CDR0000426417
Status last verified: Jan 2017
First submitted: 3 May 2005
Last updated: 8 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of Radiofrequency Ablation in High-Risk Patients With Stage IA Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT00109876
Acronym / sponsor ID: ACOSOG-Z4033
Conditions: Lung Cancer
Keywords: stage I non-small cell lung cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Alliance for Clinical Trials in OncologyUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Sep 2006
Primary completion: Aug 2012 (actual)
Study completion: Feb 2013 (actual)
First posted: 4 May 2005 (estimated)
Results: Posted 24 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To assess the overall 2-year survival rate after radiofrequency ablation (RFA).

SECONDARY OBJECTIVES:

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:

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 1 year.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (RFA therapy)	Experimental	Procedure: Computed Tomography-Guided Optical Sensor-Guided Radiofrequency AblationA 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° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (25 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Computed Tomography-Guided Optical Sensor-Guided Radiofrequency AblationAlso: CT-guided optical sensor-guided radiofrequency ablation, CT-guided optical sensor-guided RF ablationUndergo RFA	Procedure or surgery	Treatment (RFA therapy)

Primary outcome

Overall Survival at 2 Years
Time frame: 2 years from registration
Percentage of participants who were alive at 2 years. The 2 year survival was estimated using the Kaplan Meier method.

6 secondary outcomes

Overall Time to Local Failure
Time frame: Up to 2 years
Overall Time to Recurrence
Time frame: Up to 2 years
Number of Procedures Deemed Technical Successes
Time frame: Up to 2 years
Incidence of Adverse Events
Time frame: Up to 2 years
Change in Pulmonary Function From Baseline at Month 3
Time frame: Baseline and Month 3
Change in Pulmonary Function From Baseline at Month 24
Time frame: Baseline and Month 24

Results and safety

Results posted to the registry on 24 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RFA Therapy	51	51

Primary outcome: Overall Survival at 2 Years

Time frame: 2 years from registration. Number (95% Confidence Interval). Unit: percentage of participants

Measure	RFA Therapy n = 51
Value	69.8 (58.0 to 83.9)

Population analysed: All enrolled participants who met the eligibility criteria.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RFA Therapy	0 of 51 (0%)	29 of 51 (56.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Damian E. Dupuy, MD study chair

Rhode Island Hospital

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival at 2 Years (time frame: 2 years from registration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00109876.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.