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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by IsoRay Medical, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
IsoRay Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01237171
First received: November 5, 2010
Last updated: November 8, 2010
Last verified: November 2010
  Purpose

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 Intervention
NSCLC
Non Small Cell Lung Cancer
Radiation: Cesium-131 Brachytherapy Seed

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcome Study of Cesium-131 Brachytherapy Following Sub-Lobar Resection for Early Stage NSCLC

Resource links provided by NLM:


Further study details as provided by IsoRay Medical, Inc.:

Primary Outcome Measures:
  • Local Recurrence [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
    Cancer regrowth in the area where it was surgically removed


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Using questionnaires, data will be collected related to the sense of well-being experienced by the patient after treatment.


Estimated Enrollment: 40
Study Start Date: November 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

  Eligibility

Genders Eligible for Study:   Both
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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Bhupesh Parashar, M.D., Weill Corness Medical College
ClinicalTrials.gov Identifier: NCT01237171     History of Changes
Other Study ID Numbers: Cs131-Lung001
Study First Received: November 5, 2010
Last Updated: November 8, 2010
Health Authority: United States: Institutional Review Board

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

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 September 16, 2014