NCT00109876

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2005

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
4 years until next milestone

Results Posted

Study results publicly available

January 24, 2017

Completed
Last Updated

March 8, 2017

Status Verified

January 1, 2017

Enrollment Period

5.9 years

First QC Date

May 3, 2005

Results QC Date

November 29, 2016

Last Update Submit

January 26, 2017

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years from registration

Secondary Outcomes (6)

  • Overall Time to Local Failure

    Up to 2 years

  • Overall Time to Recurrence

    Up to 2 years

  • Number of Procedures Deemed Technical Successes

    Up to 2 years

  • Incidence of Adverse Events

    Up to 2 years

  • Change in Pulmonary Function From Baseline at Month 3

    Baseline and Month 3

  • +1 more secondary outcomes

Study Arms (1)

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.

Procedure: Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation

Interventions

Computed Tomography-Guided Optical Sensor-Guided Radiofrequency AblationPROCEDURE

Undergo RFA

Also known as: CT-guided optical sensor-guided radiofrequency ablation, CT-guided optical sensor-guided RF ablation
Treatment (RFA therapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

UAB Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston University Cancer Research Center

Boston, Massachusetts, 02118, United States

Location

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, 48073, United States

Location

Stony Brook University Cancer Center

Stony Brook, New York, 11794-9446, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Good Samaritan Hospital Cancer Treatment Center

Cincinnati, Ohio, 45220, United States

Location

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, 97213-2967, United States

Location

Rhode Island Hospital Comprehensive Cancer Center

Providence, Rhode Island, 02903, United States

Location

H. Clay Evans Johnson Cancer Center at Memorial Hospital

Chattanooga, Tennessee, 37404, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

Location

Providence Cancer Center at Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

Providence Cancer Center at Holy Family Hospital

Spokane, Washington, 99207, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Results Point of Contact

Title
Damian E. Dupuy, MD
Organization
Rhode Island Hospital/Alpert Medical School
ddupuy@lifespan.org
401 - 444 - 5184

Study Officials

  • Damian E. Dupuy, MD

    Rhode Island Hospital

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2005

First Posted

May 4, 2005

Study Start

September 1, 2006

Primary Completion

August 1, 2012

Study Completion

February 1, 2013

Last Updated

March 8, 2017

Results First Posted

January 24, 2017

Record last verified: 2017-01

Locations

US(17)