- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00641238
Outcome of Patients With Lung Masses Who Are Treated With Radiofrequency Ablation (RFA)
Clinical Follow-up of Patients Treated With Radiofrequency Ablation of Lung Masses.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
Syracuse, New York, United States, 13201
- Upstate Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with lung masses
- Patients who consent to radiofrequency ablation of mass
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Early stage NSCLC
Early stage non-small cell lung cancer
|
Radiofrequency ablation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Survival
Time Frame: 5 years after diagnosis of NSCLC
|
5 years after diagnosis of NSCLC
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ernest Scalzetti, MD, State University of New York - Upstate Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SUNYUMU 4886
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-small Cell Lung Cancer (NSCLC)
-
H. Lee Moffitt Cancer Center and Research InstituteNestle Health ScienceWithdrawnNSCLC | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | NSCLC Stage IIIB | Non-small Cell Lung Cancer Stage IIIB | NSCLC, Stage IIIA | Non-small Cell Lung Cancer Stage ⅢAUnited States
-
ElephasBeaufort CRORecruitingNSCLC | Non Small Cell Lung Cancer | Metastatic Non Small Cell Lung Cancer | Metastatic NSCLC - Non-Small Cell Lung CancerUnited States
-
Mythic TherapeuticsRecruitingNon-Small Cell Lung Cancer | NSCLC | Advanced Non-Small Cell Lung Cancer | NSCLC Stage IV | NSCLC Stage IIIB | Advanced Non-Small Cell Squamous Lung Cancer | Advanced Non-Small Cell Non-Squamous Lung CancerUnited States, Australia, Korea, Republic of, United Kingdom
-
Jun Zhang, MD, PhDGenentech, Inc.; ExelixisNot yet recruitingLung Cancer | NSCLC Stage IV | Advanced NSCLC | Metastatic NSCLC - Non-Small Cell Lung CancerUnited States
-
Memorial Sloan Kettering Cancer CenterRecruitingNSCLC | Non Small Cell Lung Cancer | Non Small Cell Lung Cancer Metastatic | NSCLC Stage IV | Non-small Cell CarcinomaUnited States
-
University of Alabama at BirminghamSanofiCompletedNon-small Cell Lung Cancer (NSCLC) | Metastatic NSCLC | Stage IV NSCLCUnited States
-
Oslo University HospitalAstraZenecaActive, not recruitingCancer | NSCLC | Non Small Cell Lung Cancer | NSCLC, Stage III | Non Small Cell Lung Cancer Stage IIINorway, Finland, Lithuania, Estonia
-
Heather WakeleeNovartis; Genentech, Inc.TerminatedNon-small Cell Lung Cancer (NSCLC), Recurrent | Non-small Cell Lung Cancer (NSCLC), Stage IVUnited States
-
Radiotherapy Oncology Centre "Santa Maria" HospitalPaola Anselmo,MD; Michelina Casale,PhD; Fabio Trippa,MDRecruitingNSCLC | Non Small Cell Lung Cancer | EGF-R Positive Non-Small Cell Lung Cancer | Non Small Cell Lung Cancer Metastatic | NSCLC Stage IV | Oligometastatic Disease | Non-Small Cell Squamous Lung Cancer | Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor | Non-Small Cell Adenocarcinoma and other conditionsItaly
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
Clinical Trials on Radiofrequency ablation
-
Assistance Publique - Hôpitaux de ParisTerminatedHepatocellular CancerFrance
-
Xijing HospitalUnknown
-
Oxford University Hospitals NHS TrustRoyal Bournemouth and Christchurch Hospitals NHS Foundation TrustCompleted
-
Mansoura UniversityUnknownChronic Knee OsteoarthritisEgypt
-
Allevio Pain Management ClinicRecruitingShoulder Pain Chronic | Faceto-genic Neck Pain | Faceto-genic HeadacheCanada
-
Southwest Hospital, ChinaCompleted
-
University of CalgaryRecruitingOsteoarthritis, KneeCanada
-
Assistance Publique - Hôpitaux de ParisCompletedHepatocellular CarcinomasFrance
-
Hangzhou Broncus Medical Co., Ltd.Shanghai Chest HospitalRecruitingStage IA Lung CancerChina
-
Aalborg University HospitalOdense University Hospital; St. Antonius HospitalTerminatedParoxysmal Atrial Fibrillation.Netherlands, Denmark