A Phase II Trial of Pre-operative Chemoradiotherapy Followed by Surgical Resection in Pancoast Tumors: Initial Report of Japan Clinical Oncology Group Trial (JCOG 9806)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- 3-year survival rate
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the trimodality (concurrent chemoradiotherapy followed by surgical resection) approach in superior sulcus tumors.
详细描述
Pre-operative radiotherapy has long been the community standard in Pancoast, or superior sulcus tumor. However, both complete resection rate (-50%) and long-term survival (-30%) are poor and unchanged for 40 years. Concurrent chemoradiotherapy has been shown to be beneficial in unresectable stage III non-small cell cancer. Surgery after induction chemoradiotherapy thus is a promising treatment strategy, and in fact, SWOG reported favorable results of this trimodality approach in superior sulcus tumor. The current trial is a Japanese, cooperative, multi-center, prospective one to evaluate its safety and efficacy.
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
- 15 Years 至 74 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed, pathologically documented non-small cell lung cancer (NSCLC)
- •Invasion to the first rib or more superior chest wall
- •Age: 15-74 years old
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Ample organ function
- •No prior chemo- or radiotherapy
- •Signed informed consent
排除标准
- •Metastasis to, or involvement of, mediastinal node (N2)
- •Distant metastasis or dissemination to pleura/pericardium
- •Active concomitant malignancy
- •Unstable angina, recent myocardial infarction, heart failure
- •Uncontrolled diabetes or hypertension
- •Pregnant or lactating women
- •Other severe complications
结局指标
主要结局
3-year survival rate
次要结局
- post-surgical morbidity/mortality
- local control rate
- complete resection rate