NCT00687986终止3 期
A Randomized Clinical Trial of Surgery Versus Radiosurgery (Stereotactic Radiotherapy) in Patients With Stage IA NSCLC Who Are Fit to Undergo Primary Resection
Amsterdam UMC, location VUmc2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2008年10月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- local and regional control
研究概览
简要总结
The standard treatment for an early stage I lung cancer is surgery. However, surgery can be associated with complications and long-term impairment of the quality of life of patients. Stereotactic radiotherapy (SRT) is a outpatient technique which allows for local control rates that are comparable to those achieved using surgery. In this study, patients with stage IA non-small cell lung cancer will be randomized to either surgery or SRT in order to study the local and regional tumor control, quality of life and treatment costs at 2- and 5-years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 with a cytological or histological diagnosis of stage IA non-cell lung cancer diagnosed in accordance with Dutch CBO guidelines [2004]. When no pathological diagnosis is available, a patient with a new or growing pulmonary lesion with radiological features consistent with malignancy AND a lesion showing uptake on a FDG-PET scan will be eligible [Herder 2005].
- •No evidence of regional or distant metastases on a standardized FDG-PET scan within 6 weeks of any protocol treatment .
- •The medial extension of tumors should be least 2 cm away from main and lobar bronchi, and also minimum of 1.5 cm from large peripheral blood vessels such as the aorta and main pulmonary artery. Lesions of at least 2 cm from the mediastinal pleura will be eligible if the responsible radiation oncologist judges that the specified normal tissue tolerance doses specified in the protocol will not be exceeded.
- •Patients who are judged by a multi-disciplinary team to have 2 primary lung tumors (on the basis of clinical, radiological, FDG-PET and/or cyto-pathology findings) are eligible for randomization provided that both surgery and SRT can be performed in accordance with protocol requirements.
- •Patient should be fit to undergo a complete surgical resection of the lesion in accordance with Dutch CBO guidelines [2004]
- •Performance score of ECOG ≤ 2 before any treatment.
- •Able to comply with post-treatment follow-up
- •Patients must sign and date a written Independent Ethics Committee approved informed consent form.
排除标准
- •Prior chemotherapy or radiotherapy for the present diagnosis of NSCLC.
- •History of any active malignancy (other than NSCLC) unless treated more than 3 years with curative intent and no recurrence, with the exception of non-melanoma skin cancers or in-situ cervical cancers.
- •Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, severe cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease).
- •Concomitant treatment with any other experimental drug under investigation.
- •Pregnancy
- •Men and women of child-bearing potential not using effective means of contraception for 6 months after treatment has been completed.
结局指标
主要结局
local and regional control
时间窗: 5 years
次要结局
- Overall survival(5 years)
- quality adjusted life years (QALYs)(2 years)
研究者
SSenan
Principal investigator
Amsterdam UMC, location VUmc
研究点 (2)
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