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临床试验/NCT00280189
NCT00280189暂停不适用

A Prospective Study of Outcomes of Radiofrequency Ablation of Lung Tumors

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2003年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
72
试验地点
2
主要终点
Assess overall survival, progression-free survival and clinical response after RFA

研究概览

简要总结

The purpose of this study is to assess short and long term outcomes after radiofrequency ablation (RFA) of pulmonary malignancies in patients who are not candidates for surgical resection. This study will evaluate the efficacy of RFA for the treatment of lung tumors by assessing its impact on local tumor control, progression free survival, overall survival, dyspnea score and quality of life (QOL).

详细描述

The use of RF ablation in pulmonary tissue is not new. However previous reports have primarily been descriptions of technique and early procedural outcomes. Follow-up studies have been lacking. This study will provide information on outcomes such as rates of clinical response, overall survival, progression-free survival, dyspnea and QOL.

The determination of the efficacy of this technique with this study could make an important contribution to the management of patients with pulmonary malignancies with high operative risk for resection. A minimally invasive alternative for tumor destruction could potentially improve quality of life by controlling local tumor progression and could provide longer survival when compared to current non-surgical options. This pilot study will determine the potential utility and effectiveness of RFA treatment of lung tumors, and whether to further evaluate this therapy in prospective randomized clinical trials compared to other conventional modalities.

Lung cancer is currently the most common cause of cancer-related death in the USA and represents the second most common malignancy in both men and women with 171,400 new cases in the year 1999. Unfortunately, the majority of patients present with advanced disease. Despite advances in the management of this disease, the best 5-year survival for stage I remains around 70% for patients who have undergone surgical resection. Complete resection provides the best chance for cure and remains the gold standard of therapy for patients with acceptable surgical risk.

The role of surgical resection of pulmonary metastasis in selected patients is widely accepted, and a survival advantage of aggressive surgical therapy has been demonstrated. Surgical series have demonstrated 5-year survival of 25-42% in the surgical treatment of pulmonary metastasis from different primaries including colorectal cancer osteogenic sarcoma, melanoma, and others. In a prospective study of 5,206 cases of lung metastasectomy, the International Registry of Lung Metastases reported an actuarial survival of 36% at 5 years and 26% at 10 years. These results compared favorably with those who had an incomplete resection achieving a survival of 13% at 5 years and 7% at 10 years.

The standard resections for primary lung cancer include lobectomy or pneumonectomy depending on the size and location of the tumor. Limited resections, including segmentectomy or wedge resection of the lung, are the standard treatment for limited metastases and are good alternatives for patients with primary lung cancer and poor lung function who cannot tolerate a larger resection. However, a prospective randomized trial to address the role of limited resection for primary lung cancer was performed by the Lung Cancer Study Group in 276 patients with T1N0 NSCLC. Patients in the limited resection group suffered a 50-75% increase in local recurrence rate, but no survival difference was seen between the two groups. Limited resection however should continue to be viewed as a good option for metastasectomy but a compromising operation for primary lung cancer.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Have stage I or II primary lung cancer and who are felt not to be candidates for resection based upon co-morbid disease or who refuse lung resection.
  • Have metastatic tumors to the lung, and who meet criteria for metastasectomy but who are felt not to be candidates for resection of all metastases. All metastases should be treatable by RFA alone or in combination with resection.
  • Have positive tissue diagnosis by previous resection (less than 6 months) or by radiologic biopsy.
  • Have clinically suspicious disease defined as a new lesion on chest CT or a suspicious PET scan.
  • Have RF ablation target lesions of 4 centimeters or less in diameter.

排除标准

  • If the lesion is centrally located, less than 3 centimeters from the hilum.
  • If the target lesion is greater than 4 centimeters in diameter.
  • If the lesion is metastatic and the primary site is not controlled.
  • If extra-thoracic metastatic disease is present.
  • If there are more than 3 tumors in one lung.
  • If there are greater than 6 metastatic tumors in total (bilateral).
  • If it is felt that all metastases cannot be treated by RFA alone or in combination with resection.
  • If the patient is pregnant or nursing at the time of the procedure.
  • If the patient has malignant pleural effusion.
  • If the patient is unwilling or unable to provide consent for the procedure.
  • If the patient is less than 18 years of age (the short form [SF]-36 is not designed for patients less than 18 years of age).

结局指标

主要结局

Assess overall survival, progression-free survival and clinical response after RFA

时间窗: Until disease progression or death

次要结局

  • To characterize QOL before and after RFA treatment(Every 3 months for 1 year then annually)
  • To assess procedure related outcomes after RFA of lung tumors, in particular, measuring length of stay, morbidity and mortality and requirements for chest tube drainage(Within 30 days of RFA procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James Luketich

Professor

University of Pittsburgh

研究点 (2)

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