Risk-adapted Stereotactic Body Radiotherapy for Early Non-Small Cell Lung Cancer Using the VERO Stereotactic Body Radio Therapy System
2014年9月8日 更新者：Christine Collen, MD.、Universitair Ziekenhuis Brussel
Phase II Protocol for Risk-adapted Stereotactic Body Radio Therapy for Stage T1-T3N0 Non-Small Cell Lung Carcinoma
The purpose of this study is to perform prospective data analysis on tumor response in terms of local tumor control after 2 years, potential acute and late toxicity and survival in patients with non-metastatic, non-small-cell lung cancer treated by radiotherapy that are medically inoperable due to coexisting comorbidities or that refuse surgery.
SBRT regimens used will be 4 fractions of 12 Gy or 3 fractions of 17 Gy depending on tumor location in a risk-adapted approach.
研究概览
研究类型
介入性
注册 (预期的)
58
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Brussels
-
Jette、Brussels、比利时、1090
- 招聘中
- UZ Brussel Radiotherapie dienst
-
接触：
- Christine Collen, MD
- 电话号码：+3224763438
- 邮箱：christine.collen@uzbrussel.be
-
接触：
- Harijati Versmessen, MD
- 电话号码：+3224763407
- 邮箱：harijati.versmessen@uzbrussel.be
-
首席研究员：
- Christine Collen, MD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 90年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Stage T1,T2,T3N0M0 NSCLC, histological confirmation either by biopsy or cytology
- Maximal tumor diameter of 6 cm
- Only T3 lesions based upon thoracic wall involvement, only 1 lesion
- Informed consent is required
- Life expectancy of at least 6 months
- Age >/= 18 y.
- Karnofsky score ≥ 70 or ECOG score ≤ 2
- Inoperable patients or patients refusing surgery
- Patients with measurable lesion (according to RECIST criteria)
Exclusion Criteria:
- Diagnosis of small cell lung cancer
- Lymph node involvement
- Prior radiotherapy to the chest and/or mediastinum
- No chemotherapy and/or targeted treatment within 3 months before SBRT
- Pregnant or lactating women
- Known allergy for CT contrast
- No FDG-PET
- Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
- Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to return for follow-up visits, extreme degradation of lung function tests and patients not likely to complete the study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Radiotherapy
For centrally located T1 and T2 lesions 4 x 12 Gy over 2 weeks will be delivered.
Lesions located peripherally will be treated with 3 x 17 Gy, also delivered within 2 weeks.
For both schedules, there should be a minimum of 40 hours and a maximum of 8 days between 2 separate fractions.
There should be a maximum of 2 fractions per week.
|
Radiation: Fractionated stereotactic body radiation therapy For centrally located T1 and T2 lesions 4 x 12 Gy over 2 weeks will be delivered.
Lesions located peripherally will be treated with 3 x 17Gy, also delivered within 2 weeks.
For both schedules, there should be a minimum of 40 hours and a maximum of 8 days between 2 separate fractions.
There should be a maximum of 2 fractions per week.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Toxicity of grade 3+ as assessed by NCI CTCAE v4.0
大体时间：From start of SBRT until 1 year. After 1 year until end of follow-up for late toxicity
|
To monitor potential toxicity in patients with stage T1,T2,T3 N0 non-small cell lung carcinoma (NSCLC), treated with primary stereotactic body radiation therapy (SBRT)
|
From start of SBRT until 1 year. After 1 year until end of follow-up for late toxicity
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to local progression
大体时间：every 3 months for the first 2 years. From 3 to 5 years every 6 months. After From start of SBRT until date of death, regional fialure of last follow-up. Aanalysis occurs when all patients have been potentially followed for 24 months.
|
Overall survival, local progression free survival, disease free survival, time from start of SBRT to death, local, regional or disseminated recurrence.
|
every 3 months for the first 2 years. From 3 to 5 years every 6 months. After From start of SBRT until date of death, regional fialure of last follow-up. Aanalysis occurs when all patients have been potentially followed for 24 months.
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality of life
大体时间：baseline at inclusion, at 1 month-, 3 months- and 12 months from start SBRT
|
Quality of life
|
baseline at inclusion, at 1 month-, 3 months- and 12 months from start SBRT
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Christine Collen, MD、UZ Brussel Radiotherapie dienst
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年1月1日
初级完成 (预期的)
2017年12月1日
研究注册日期
首次提交
2014年5月27日
首先提交符合 QC 标准的
2014年8月22日
首次发布 (估计)
2014年8月25日
研究记录更新
最后更新发布 (估计)
2014年9月9日
上次提交的符合 QC 标准的更新
2014年9月8日
最后验证
2014年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.