Cesium-131 Seed Brachytherapy Plus Subtotal Resection for Lung Cancer Patients Who Are Not Candidates for Lobectomy or Patients With High Risk of Local Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
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.
详细描述
A lobectomy (removal of a full lobe of the lung or removal of ¼ - 1/5 of the entire lungs) is a part of the primary curative treatment for people with lung cancer. 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 that cancer was not controlled as well in individuals who had the wedge resection. Localized disease wedge resection alone is therefore considered an inadequate operation. This inadequacy, however, can be compensated for if radiation seeds are implanted (added) to the site of wedge resection.
Iodine-125 radiation seeds are currently the most common radioactive material implanted in the operative bed after wedge resection. However, I-125 has a half-life of 60 days. This causes the patient to be "radioactive" for 6 months to 1 year. When an individual is radioactive they must take necessary precautions that result in a significantly compromised quality of life. These precautions are 1) no continuous close contact (less than 3 feet) for a significant duration of time (more than 15 minutes), 2) no close contact with pregnant women and children, 3) adequate precautions especially during air travel and 4) risk of radioactive seed displacement several months.
The local control of cancer with this treatment is >95%_ %. Cesium-131 is a novel radiation seed that has the same energy as I-125 but has a much shorter half life (9days). That means that Cs-131 seeds give off all their radiation at a faster rate. When a radioactive seeds gives off all of its radiation it is no longer radioactive and the dangers of radioactivity no longer exist. With a half life of 9 days, Cs-131 gives off all of its radiation in 1 month. This significantly reduces the time when the patient is 'radioactive'. Therefore, Cs-131 has less of a negative affect on quality of life than I-125.
In addition, because of Cs-131's significantly faster rate of radiation dissemination, faster growing cancers (especially lung cancer) cells should be killed more efficiently thereby increasing cancer control rates. In addition, the lesser total radiation time may result in reduced short term and long term side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Resected lung cancers with positive margins
排除标准
- •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.)
结局指标
主要结局
Efficacy
时间窗: 5 years
To assess local recurrence rate after a wedge resection and Cs-131 implant.
次要结局
- Quality of Life(pre-surgery, 3 months, 12 months, 24 months)