WithdrawnNot applicableNCT01757158
Official study title

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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCs-131 brachytherapy seeds

The study team can explain what participation involves.

Who it may be forEarly-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 27, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Withdrawn

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Weill Medical College of Cornell University

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
Weill Medical College of Cornell University
Interventions being studied
Radiation: Cs-131 brachytherapy seeds
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. Patients must have suspicious lung nodule for clinical stage I/recurrent 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. 5. Resected lung cancers with positive margins

Reasons someone may not be able to joinExclusion criteria

1. Patient has already received high dose radiation to the area 2. Cancerous nodule is very close to the esophagus or spinal chord, thereby increasing the risk of radiation treatment 3. Pregnancy or unwillingness to practice a form of birth control (i.e. abstinence, oral contraceptives, etc.)

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Weill Cornell Medical CollegeNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 27, 2017. Always confirm current availability with the study team.

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