Lung Cancer Trials Ask AI to find trials
CompletedNot applicableNCT00109876
Official study title

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

Study 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.

Ask AI to explain this study
Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedComputed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 8, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?17 U.S. locations

Locations may change over time.

Who runs it?Alliance for Clinical Trials in Oncology

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
Alliance for Clinical Trials in Oncology
Interventions being studied
Procedure: Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Early-stage or resectable→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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)

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • UAB Comprehensive Cancer CenterBirmingham, Alabama
  • Jonsson Comprehensive Cancer Center at UCLALos Angeles, California
  • University of California Davis Cancer CenterSacramento, California
  • Massachusetts General HospitalBoston, Massachusetts
  • Boston University Cancer Research CenterBoston, Massachusetts
  • William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan
  • Stony Brook University Cancer CenterStony Brook, New York
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina
  • Good Samaritan Hospital Cancer Treatment CenterCincinnati, Ohio
  • Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon
  • Rhode Island Hospital Comprehensive Cancer CenterProvidence, Rhode Island
  • H. Clay Evans Johnson Cancer Center at Memorial HospitalChattanooga, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 8, 2017. Always confirm current availability with the study team.

View original record ↗