Cesium-131 Seed Brachytherapy Plus Subtotal Resection for Lung Cancer Patients
The primary curative treatment of lung cancer patients is surgery, chemotherapy and/or radiation therapy (either or all depending on the extent of disease). Surgical resection usually requires removal of a lobe of the lung (lobectomy). There are, however, some patients who are unable to have a lobectomy. There are several reasons why a patient should not have a lobectomy including prior operations in the same area of the lung or poor lung functions. Sub-lobe operations (less than a full lobectomy), are alternatives for these patients. Types of sub-lobe operations include wedge resection or segmentectomy.
However, a randomized trial in early stage lung cancer patients that compared lobectomy versus wedge resection showed worse local control of cancer with wedge resection. Therefore, localized disease wedge resection is considered an inadequate operation. This inadequacy can be compensated if radiation seeds are added to the site of wedge resection. Iodine-125 (I-125) is the most commonly used radiation seed for this purpose. I-125, however, unfortunately has a relatively long half life (time taken for activity to become half) of 2 months. Therefore, the patient is technically 'radioactive' for an average of 6 months to 1 year. This can seriously compromise quality of life.
Cesium-131 is another radiation seed that may more effectively treat lung cancer patients. Cs-131 has been previously used in prostate cancer successfully. Cs-131 has similar energy to I-125 but has a much shorter half life (9days as compared to 60 days for I-125). Patients who receive Cs-131 radiation seeds are expected to be radioactive for 30 days (1 month) as compared to 180 days (6 months) with I-125. The objective of this study is the use Cs-131 radiation seeds in lung cancer patients who are planning to undergo a wedge resection for localized disease and follow the patients for cancer control and toxicity. These results will be compared to pre-existing data for I-125 treatment outcomes in lung cancer patients who have had a wedge resection for localized disease.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cesium-131 Seed Brachytherapy Plus Subtotal Resection for Lung Cancer Patients Who Are Not Candidates for Lobectomy or Patients With High Risk of Local Recurrence|
- Efficacy [ Time Frame: 5 years ] [ Designated as safety issue: No ]To assess local recurrence rate after a wedge resection and Cs-131 implant.
- Quality of Life [ Time Frame: pre-surgery, 3 months, 12 months, 24 months ] [ Designated as safety issue: No ]To assess quality of life (as related to side effects) of Cs-131 seed placement after limited surgical resection in lung cancers and compare it to already existing data on I-125 tolerability.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Radiation: Cs-131 brachytherapy seeds
Please refer to this study by its ClinicalTrials.gov identifier: NCT01757158
|Contact: Mei-Ki Chan, M.A.||firstname.lastname@example.org|
|Contact: Bhupesh Parashar, M.D.||email@example.com|
|United States, New York|
|Weill Cornell Medical College||Recruiting|
|New York, New York, United States, 10065|
|Contact: Mei-Ki Chan, M.A. 212-746-9297 firstname.lastname@example.org|
|Contact: Bhupesh Parashar, M.D. 212-746-3612 email@example.com|
|Sub-Investigator: Nasser Altorki, M.D.|
|Principal Investigator: Bhupesh Parashar, M.D.|
|Sub-Investigator: Paul Lee, M.D.|
|Sub-Investigator: Subroto Paul, M.D.|
|Sub-Investigator: Jeffrey Port, M.D.|
|Sub-Investigator: Dattatreyudu Nori, M.D.|
|Sub-Investigator: A. Gabriella Wernicke, M.D.|
|Principal Investigator:||Bhupesh Parashar, M.D.||Weill Medical College of Cornell University|