Phase I Study of Concurrent Radiotherapy With Weekly Topotecan for Primary Treatment of Inoperable Localized Non-small Cell Lung Cancer (NSCLC) (Stage I to IIIA)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- The primary endpoint is the establishment of the maximum tolerated dose (MTD) of topotecan given weekly with RT
研究概览
简要总结
Given the activity of single-agent Topotecan in NSCLC, there is both scientific rationale and a medical interest in studying this agent in combination with radiation. In addition, Topotecan administered on a weekly basis offers advantages over the daily x 5 regimen, i.e., the convenience of administration and fewer visits to the clinic.
详细描述
This is a study of chemoradiation for patient with inoperable non small cell lung cancer with poor pulmonary function. These patients have usually very limited treatment options because of the compromised lung function. Chemoradiation is usually superior to radiation alone, but has not been extensively tested in this patient population. Topotecan is a drug approved for lung cancer that has synergistic activity with radiation. The study will determine what is the safest dose of topotecan to use with radiation in this patient population
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically proven non-small cell lung cancer Stage I to IIIA.
- •Inoperable lung cancer because of poor respiratory lung function, or other medical reasons, as determined by the thoracic surgeon.
- •Age > 18 years
- •Life expectancy of > 12 weeks
- •Normal hematologic, liver, and renal function
- •No metastatic disease as determined by CT-PET scanning and bone scan.
- •No brain metastasis by MRI
- •No contraindication to radiotherapy
排除标准
- •Patients with uncontrolled CNS metastases.
- •Active systemic infection.
- •Serious, uncontrolled intercurrent medical or psychiatric illness.
- •Secondary active primary malignancy.
- •Inability to comply with requirements of the study.
- •Any metastases outside of the mediastinum
- •Histologically positive pleural or pericardial effusion
- •Any chemotherapy within five years prior to enrollment on this protocol
- •Prior radiotherapy administered to the chest
- •Women who are pregnant or lactating
- •FEV1 < 1 liter/minute
结局指标
主要结局
The primary endpoint is the establishment of the maximum tolerated dose (MTD) of topotecan given weekly with RT
时间窗: Treatment with topotecan will last until RT is completed. Treatment will stop if there is disease progression or unacceptable toxicity
次要结局
未报告次要终点