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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage I non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UAB Comprehensive Cancer Center
  • Jonsson Comprehensive Cancer Center at UCLA
  • University of California Davis Cancer Center
  • Massachusetts General Hospital
  • Boston University Cancer Research Center
  • William Beaumont Hospital - Royal Oak Campus
  • Stony Brook University Cancer Center
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • Good Samaritan Hospital Cancer Treatment Center
  • Providence Cancer Center at Providence Portland Medical Center
  • Rhode Island Hospital Comprehensive Cancer Center
  • H. Clay Evans Johnson Cancer Center at Memorial Hospital
  • Medical City Dallas Hospital
  • Huntsman Cancer Institute at University of Utah
  • Providence Cancer Center at Sacred Heart Medical Center
  • Providence Cancer Center at Holy Family Hospital
  • Medical College of Wisconsin Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (RFA therapy)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 3, 2005
Last Updated
January 26, 2017
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00109876
Brief Title
Radiofrequency Ablation in Treating Patients With Stage I Non-Small Cell Lung Cancer
Official Title
A Pilot Study of Radiofrequency Ablation in High-Risk Patients With Stage IA Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage I non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (RFA therapy)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation
Other Intervention Name(s)
CT-guided optical sensor-guided radiofrequency ablation, CT-guided optical sensor-guided RF ablation
Intervention Description
Undergo RFA
Primary Outcome Measure Information:
Title
Overall Survival at 2 Years
Description
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
Secondary Outcome Measure Information:
Title
Overall Time to Local Failure
Description
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
Title
Overall Time to Recurrence
Description
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
Title
Number of Procedures Deemed Technical Successes
Description
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
Title
Incidence of Adverse Events
Description
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
Title
Change in Pulmonary Function From Baseline at Month 3
Description
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
Title
Change in Pulmonary Function From Baseline at Month 24
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damian E. Dupuy, MD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
UAB Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston University Cancer Research Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
William Beaumont Hospital - Royal Oak Campus
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Stony Brook University Cancer Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-9446
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Good Samaritan Hospital Cancer Treatment Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Providence Cancer Center at Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213-2967
Country
United States
Facility Name
Rhode Island Hospital Comprehensive Cancer Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
H. Clay Evans Johnson Cancer Center at Memorial Hospital
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Huntsman Cancer Institute at University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Providence Cancer Center at Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Providence Cancer Center at Holy Family Hospital
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States
Facility Name
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

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

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