Outcome of Patients With Lung Masses Who Are Treated With Radiofrequency Ablation (RFA)

This study has been completed.
Sponsor:
Information provided by:
State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT00641238
First received: March 17, 2008
Last updated: April 26, 2011
Last verified: March 2008
  Purpose

We are collecting clinical notes and results of imaging studies (CT and PET scans) from referring physicians who follow the clinical status of patients treated with radiofrequency ablation (RFA). The research objective is to determine whether the patients with (RFA) remain alive, and whether they are in remission or have progressive/ recurrent malignancy


Condition
Non-small Cell Lung Cancer (NSCLC)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Follow-up of Patients Treated With Radiofrequency Ablation of Lung Masses.

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Enrollment: 20
Study Start Date: March 2004
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Radiofrequency ablation (RFA) is a relatively new treatment for localized forms of cancer. It requires that a device called a needle-electrode be placed in the tumor. Radiofrequency energy can be passed through this needle-electrode that heats the tissue surrounding the needle tip. If the heating effect is intense enough and maintained for a long enough period of time, the cells in the treated area will be destroyed. RFA has been used in the lung to treat metastases from cancers originating in other sites, and cancers other than small cell carcinoma (Non-small cell lung cancer, NSCLC) that arise in the lung itself.

Pre-treatment assessment includes evaluation of the patient and the tumor itself; this determines whether the patient meets the entry criteria. These criteria are:

  • Patient has a biopsy-proven NSCLC, with no other sites of disease, and with a tumor small enough to treat (usually <4 cm). Clinical stage I NSCLC.
  • Patient is not a candidate for surgical removal of the cancer, or refused surgery.
  • Patient is not a candidate for radiation therapy, or refused radiation therapy.
  • Patient has > 6 month life expectancy. The procedure is performed similar to a needle biopsy of the lung, under CT guidance. Placement of the needle-electrode is similar to needle placement for CT-guided biopsy. Appropriate positioning of the needle-electrode is confirmed by CT imaging. Radiofrequency energy is applied to the needle-electrode and the tissue is monitored continuously for electrical changes that indicate tissue destruction. After completion of the treatment, the needle-electrode is removed. The patient is followed for at least three hours prior to discharge. Complications that can be discovered at this time are pulmonary hemorrhage (bleeding in the lung) and pneumothorax (leakage of air from the lung at the site of needle puncture). Subsequent follow-up usually consists of a CT scan at three months and six months after the RFA, and then at six month intervals after that, to see whether the tumor successfully has been transformed into a scar, or continues to grow.

This follow-up is conducted by the referring physician, who may not be associated with this institution. We gather and record this follow-up information until the patient dies, has documented recurrence of the cancer, or completes five years of post- treatment observation. In the cases of recurrence, we also determine whether the tumor is re-growing at the treatment site, or at distant sites that appeared to be uninvolved at the time of treatment.

Statistical analysis will be performed using de-identified patient data. Measures of interest include lifetable determination of median survival and 5-year overall survival. Patients will undergo no study-related procedures during the follow-up period. Chemotherapy given at any time following RFA, at the discretion of a medical oncologist, will not result in exclusion of the patient from analysis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with clinical stage I NSCLC that are treated with Radiofrequency ablation.

Criteria

Inclusion Criteria:

  • Patients with lung masses
  • Patients who consent to radiofrequency ablation of mass
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00641238

Locations
United States, New York
Upstate Medical University
Syracuse, New York, United States, 13201
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: Ernest Scalzetti, MD State University of New York - Upstate Medical University
  More Information

No publications provided

Responsible Party: Ernest Scalzetti, MD, SUNY Upstate Medical University
ClinicalTrials.gov Identifier: NCT00641238     History of Changes
Other Study ID Numbers: SUNYUMU 4886
Study First Received: March 17, 2008
Last Updated: April 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:
NSCLC
lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 21, 2014