NCT00887315终止2 期
A Randomized Phase II Trial of Docetaxel, Cisplatin, and Hypofractionated Radiotherapy Versus Docetaxel and Cisplatin for Limited Volume Stage IV Non-small Cell Lung Cancer: The Synergistic Metastases Annihilation With Radiotherapy and Docetaxel (Taxotere) [SMART] Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- 1-Year Overall Survival
研究概览
简要总结
Primary goal of the study is to assess the overall survival of the addition of hypofractionated image guided radiotherapy concurrently with Docetaxel and cisplatin. Survival will be assessed at 1 year from the date of study enrollment to date of death.
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
- •Age 18 years or older
- •Life expectancy > 6 months
- •Histologically or cytologically confirmed diagnosis of NSCLC
- •Patients with AJCC stage IV cancer with distant metastases and without malignant pleural or pericardial effusion at diagnosis and before start of study
- •Patients with pleural effusion that is transudative, cytologically negative, and non-bloody are eligible as long as they are stable and do not impair the ability to define tumor volumes.
- •If a pleural effusion is too small for diagnostic thoracentesis, the patient will be eligible.
- •Primary and regional nodal disease that is encompassable in a reasonable radiotherapy portal:
- •Patients with 1-5 sites of disease and amenable to RT therapy as seen on standard imaging (CT, MRI, bone scan, PET scan)
- •Unidimensionally measurable disease (based on RECIST) is desirable but not strictly required.
- •Patients with brain metastases are allowed as long as they meet all other inclusion criteria. Brain metastases must be treated with whole brain radiotherapy and stereotactic radiosurgery or surgical resection followed by whole brain radiotherapy.
- •ECOG performance status <2
- •No prior RT to currently involved tumor sites
- •Baseline peripheral neuropathy < grade 1
- •Room air saturation (SaO2) > 90%
- •Patients must have normal organ and marrow function
- •Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
- •Signed Informed consent
- •Inclusion of Women and Minorities
- •RT: Patient must have a completed treatment plan approved by the protocol review team
排除标准
- •Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements
- •Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF are excluded. The exclusion of patients with active coronary heart disease will be at the discretion of the attending physician.
- •Patients with significant atelectasis such that CT definition of the gross tumor volume (GTV) is difficult to determine.
- •< 1000 cc of tumor free lung.
- •Tumor volume and location which requires a lung volume-PTV >40% to receive >20 Gy (V20 <40%).
- •Patients with exudative, bloody, or cytologically malignant effusions are not eligible.
- •Pregnancy or breast feeding (Women of child-bearing potential are eligible, but must consent to using effective contraception during therapy and for at least 3 months after completing therapy)
- •Patients must have no uncontrolled active infection other than that not curable without treatment of their cancer.
- •Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate
- •Patient may not be receiving any other investigational agents.
研究组 & 干预措施
Group 1
Active Comparator
Chemotherapy only
干预措施: Docetaxel and cisplatin (Drug)
2
Active Comparator
Chemotherapy and hypofractionated image guided radiotherapy
干预措施: Docetaxel and cisplatin Plus Hypofractionated Radiotherapy (Radiation)
结局指标
主要结局
1-Year Overall Survival
时间窗: Baseline to death from any cause, 1 year
Overall survival is assessed at 1 year from the date of study enrollment to date of death.
次要结局
- Overall PFS and CT Rate(>90 days)
研究者
研究点 (1)
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