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A Study of Cesium-131 Brachytherapy Following Sub-Lobar Resection for Early Stage Non Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01237171
Recruitment Status : Unknown
Verified November 2010 by IsoRay Medical, Inc..
Recruitment status was:  Recruiting
First Posted : November 9, 2010
Last Update Posted : November 9, 2010
Sponsor:
Information provided by:
IsoRay Medical, Inc.

Brief Summary:
For patients diagnosed with early (Stage I) non-small cell lung cancer, a lobe of lung is usually removed at surgery to treat the cancer. For some patients, the removal of a lobe of lung may leave too little lung behind for easy breathing. For some of these patients, it may be possible to perform a smaller-scale surgery ("sub-lobar resection") and place a radioactive implant behind to prevent the cancer from growing back. This study will see how these patients do in terms of controlling their disease treated with a radioactive implant called Cesium-131.

Condition or disease Intervention/treatment
NSCLC Non Small Cell Lung Cancer Radiation: Cesium-131 Brachytherapy Seed

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcome Study of Cesium-131 Brachytherapy Following Sub-Lobar Resection for Early Stage NSCLC
Study Start Date : November 2010
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Group/Cohort Intervention/treatment
Sub-lobar resection with Cesium-131
All enrolled patients will undergo sub-lobar resection and brachytherapy implant with Cesium-131 in an effort to study and quantify recurrence/control patterns.
Radiation: Cesium-131 Brachytherapy Seed
85 Gray Dose
Other Name: Sealed Brachytherapy Source CS-1 (IsoRay Medical)



Primary Outcome Measures :
  1. Local Recurrence [ Time Frame: 3 Years ]
    Cancer regrowth in the area where it was surgically removed


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 2 years ]
    Using questionnaires, data will be collected related to the sense of well-being experienced by the patient after treatment.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with clinical stage I non-small cell lung cancer who are not candidates for full lobectomy.
Criteria

Inclusion Criteria:

  1. Patients must have suspicious lung nodule for clinical stage I/recurrent non-small cell Lung Cancer
  2. Mass Tumor size < 7 cm
  3. Patient must have a CT scan of the chest with upper abdomen within 90 days prior to date of pre-registration.
  4. Patient must have ECOG/Zubrod performance status 0,1, or 2.

Exclusion Criteria:

  1. Patient has already received high dose radiation to the area
  2. Cancerous nodule is very close to the esophagus or spinal cord, thereby increasing the risk of radiation treatment
  3. Pregnancy or unwillingness to practice a form of birth control (i.e. abstinence, oral contraceptives, etc.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01237171


Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Bhupesh Parashar, M.D.    212-746-3612    bup9001@cornell.edu   
Contact: Mei-Ki Chan, M.A.    212-746-9297    mbc2004@cornell.edu   
Principal Investigator: Bhupesh Parashar, M.D.         
Sponsors and Collaborators
IsoRay Medical, Inc.
Investigators
Principal Investigator: Bhupesh Parashar, M.D. Weill Medical College of Cornell University

Responsible Party: Bhupesh Parashar, M.D., Weill Corness Medical College
ClinicalTrials.gov Identifier: NCT01237171     History of Changes
Other Study ID Numbers: Cs131-Lung001
First Posted: November 9, 2010    Key Record Dates
Last Update Posted: November 9, 2010
Last Verified: November 2010

Keywords provided by IsoRay Medical, Inc.:
Brachytherapy
Lung Brachytherapy
NSCLC
Sub-lobar resection

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