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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

November 5, 2010
November 8, 2010
November 2010
May 2014   (final data collection date for primary outcome measure)
Local Recurrence [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
Cancer regrowth in the area where it was surgically removed
Same as current
Complete list of historical versions of study NCT01237171 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
A Study of Cesium-131 Brachytherapy Following Sub-Lobar Resection for Early Stage Non Small Cell Lung Cancer
Outcome Study of Cesium-131 Brachytherapy Following Sub-Lobar Resection for Early Stage NSCLC

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with clinical stage I non-small cell lung cancer who are not candidates for full lobectomy.

  • NSCLC
  • Non Small Cell Lung Cancer
Radiation: Cesium-131 Brachytherapy Seed
85 Gray Dose
Other Name: Sealed Brachytherapy Source CS-1 (IsoRay Medical)
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.
Intervention: Radiation: Cesium-131 Brachytherapy Seed
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
May 2014
May 2014   (final data collection date for primary outcome measure)

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.)
Both
Not Provided
No
United States
 
NCT01237171
Cs131-Lung001
No
Bhupesh Parashar, M.D., Weill Corness Medical College
IsoRay Medical, Inc.
Not Provided
Principal Investigator: Bhupesh Parashar, M.D. Weill Medical College of Cornell University
IsoRay Medical, Inc.
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP