Cesium-131 Seed Brachytherapy Plus Subtotal Resection for Lung Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Weill Medical College of Cornell University
Sponsor:
Collaborator:
IsoRay Medical, Inc.
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01757158
First received: March 7, 2012
Last updated: December 20, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Radiation: Cs-131 brachytherapy seeds
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To assess local recurrence rate after a wedge resection and Cs-131 implant.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
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)
Intervention Details:
    Radiation: Cs-131 brachytherapy seeds
    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.
    Other Name: Brachytherapy
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have suspicious lung nodule for clinical stage I/recurrent 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.
  5. Resected lung cancers with positive margins

Exclusion Criteria:

  1. Patient has already received high dose radiation to the area
  2. Cancerous nodule is very close to the esophagus or spinal chord, 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: NCT01757158

Contacts
Contact: Mei-Ki Chan, M.A. 212-746-9297 mbc2004@med.cornell.edu
Contact: Bhupesh Parashar, M.D. 212-746-3612 bup9001@med.cornell.edu

Locations
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    mbc2004@med.cornell.edu   
Contact: Bhupesh Parashar, M.D.    212-746-3612    bup9001@med.cornell.edu   
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.         
Sponsors and Collaborators
Weill Medical College of Cornell University
IsoRay Medical, Inc.
Investigators
Principal Investigator: Bhupesh Parashar, M.D. Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01757158     History of Changes
Other Study ID Numbers: 0908010555
Study First Received: March 7, 2012
Last Updated: December 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
lung cancer
lobectomy
local recurrence

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 02, 2014