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

Withdrawn before enrolling · Not applicable

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT01757158

Run by

Weill Medical College of Cornell University

People needed

0

Starts

2012-02-01

Expected to finish

2018-06-01

Last updated by the study team

2017-01-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

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 chord, thereby increasing the risk of radiation treatment
• Pregnancy or unwillingness to practice a form of birth control (i.e. abstinence, oral contraceptives, etc.)

Where it is running

• Weill Cornell Medical College — New York, New York, United States

Full record on ClinicalTrials.gov

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