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临床试验/NCT00469196
NCT00469196已完成2 期

Tomotherapy Treatment for Mesothelioma

AHS Cancer Control Alberta2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2006年10月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
18
试验地点
2
主要终点
Quality of Life

研究概览

简要总结

Mesothelioma is an incurable cancer involving the lining of the lung. Patients usually suffer progressive symptoms of shortness of breath and chest pain, until they ultimately succumb to the disease. While a very small number of patients qualify for aggressive treatment with surgery, chemotherapy and radiation, and enjoy long-term survival, the vast majority of patients have incurable disease. The treatment options currently available, including chemotherapy and radiation treatment, are only modestly effective at alleviating symptoms and improving life expectancy. This trial explores the use of new radiation technology (tomotherapy), to treat mesothelioma more aggressively than has been possible before. Tomotherapy's ability to treat unusual shaped tumours, particularly when they are wrapped around sensitive normal tissues (the lung), enable higher doses of radiation to be used and this may improve its effectiveness. We will treat 17 patients with tomotherapy and assess the breathing, symptoms, and quality of life of the patients before and after treatment

详细描述

Background

Malignant mesothelioma of the pleura is one of the most challenging diseases to treat in oncology. It is often associated with previous exposure to asbestos many years in the past with the mean latency period between asbestos exposure and the development of mesothelioma being approximately 48 years. The disease most commonly presents in the fifth to seventh decade of life, and the natural history is one of relentless progression and eventual death in nearly all patients. It can metastasize to regional nodes and/or distant sites, but most of the morbidity and mortality comes from local disease in the chest, causing progressive constriction, and death from pulmonary insufficiency or infection. Common clinical manifestations can include pleural effusions, superior vena cava obstruction, dysphagia, and laryngeal nerve palsy. Median survival rates are generally less than one year from the time of diagnosis, although there may be a small subset of patients with more indolent disease that have longer survival durations. Patients generally suffer from significant symptoms over the course of their illness, particularly progressive dyspnea and chest pain.

Treatment options with mesothelioma

The treatment of mesothelioma has been characterized by disappointment. The only form of "curative" treatment that has been attempted is a combination of surgery (extrapleural pneumonectomy), chemotherapy, and radiation treatment to the hemithorax. This was described by Sugerbaker, who reported 5-year survival rates of 22% of 120 patients treated. Unfortunately, this approach is only possible for early stage disease (clinical stage I with no nodal involvement) in the absence of comorbid medical illness, and the vast majority of patients present with disease too advanced to consider this approach.

Role of radiotherapy in malignant mesothelioma:

研究设计

研究类型
Interventional
分配方式
Non Randomized
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

入选标准

  • histologic mesothelioma
  • refused/ineligible for surgery or chemotherapy
  • life expectancy >3 months

排除标准

  • contraindications to thoracic radiotherapy
  • unable to lie flat for duration of radiation therapy

结局指标

主要结局

Quality of Life

时间窗: 6 months

Disease-specific symptom control rate post-treatment, based on Palliation Index \[7\].

次要结局

  • Breathing Function(6 months)
  • Survival/Response Rate(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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