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

NCT01237171 | Withdrawn

• 1 other identifier: Cs131-Lung001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC; Non Small Cell Lung Cancer

Keywords

Brachytherapy; Lung Brachytherapy; NSCLC; Sub-lobar resection

Outcome Measures

Primary Outcomes (1)

• Local Recurrence

  Cancer regrowth in the area where it was surgically removed

  3 Years

Secondary Outcomes (1)

• Quality of Life

  2 years

Study Arms (1)

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.

Radiation: Cesium-131 Brachytherapy Seed

Interventions

Cesium-131 Brachytherapy Seed RADIATION

85 Gray Dose

Also known as: Sealed Brachytherapy Source CS-1 (IsoRay Medical)

Sub-lobar resection with Cesium-131

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients must have suspicious lung nodule for clinical stage I/recurrent non-small cell Lung Cancer
• Mass Tumor size \< 7 cm
• Patient must have a CT scan of the chest with upper abdomen within 90 days prior to date of pre-registration.
• Patient must have ECOG/Zubrod performance status 0,1, or 2.

You may not qualify if:

• Patient has already received high dose radiation to the area
• Cancerous nodule is very close to the esophagus or spinal cord, thereby increasing the risk of radiation treatment
• Pregnancy or unwillingness to practice a form of birth control (i.e. abstinence, oral contraceptives, etc.)

Sponsors & Collaborators

• IsoRay Medical, Inc.: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bhupesh Parashar, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: November 9, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: March 30, 2021

Record last verified: 2021-03

Locations

US (1)