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

Non Small Cell Lung Cancer Clinical Trial

Official title:

Outcome Study of Cesium-131 Brachytherapy Following Sub-Lobar Resection for Early Stage NSCLC

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01237171
• Other study ID #: Cs131-Lung001
• Status: Withdrawn
• Start date: November 2010
• Est. completion date: November 2010

Study information

• Verified date: March 2021
• Source: IsoRay Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.)

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer
• NSCLC

Intervention

Radiation:
• Cesium-131 Brachytherapy Seed
85 Gray Dose

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
IsoRay Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Recurrence	Cancer regrowth in the area where it was surgically removed	3 Years
Secondary	Quality of Life	Using questionnaires, data will be collected related to the sense of well-being experienced by the patient after treatment.	2 years