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

Withdrawn

• Conditions: NSCLC; Non Small Cell Lung Cancer
• Interventions: Radiation: Cesium-131 Brachytherapy Seed

• Registration Number: NCT01237171
• Lead Sponsor: IsoRay Medical, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Study First Submitted: 2010-11-05
• Study First Submitted QC: 2010-11-08
• Study First Posted: 2010-11-09
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-25
• Last Update Posted: 2021-03-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sub-lobar resection with Cesium-131	Cesium-131 Brachytherapy Seed	All enrolled patients will undergo sub-lobar resection and brachytherapy implant with Cesium-131 in an effort to study and quantify recurrence/control patterns.

Primary Outcome Measures

Name	Time	Method
Local Recurrence	3 Years	Cancer regrowth in the area where it was surgically removed

Secondary Outcome Measures

Name	Time	Method
Quality of Life	2 years	Using questionnaires, data will be collected related to the sense of well-being experienced by the patient after treatment.

Trial Locations

Locations (1)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States