Skip to content

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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01237171
Enrollment
0
Registered
2010-11-09
Start date
2010-11-30
Completion date
2010-11-30
Last updated
2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer, NSCLC

Keywords

Brachytherapy, Lung Brachytherapy, NSCLC, Sub-lobar resection

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.

Interventions

RADIATIONCesium-131 Brachytherapy Seed

85 Gray Dose

Sponsors

IsoRay Medical, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
Local Recurrence3 YearsCancer regrowth in the area where it was surgically removed

Secondary

MeasureTime frameDescription
Quality of Life2 yearsUsing questionnaires, data will be collected related to the sense of well-being experienced by the patient after treatment.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026