NCT00945451已完成不适用
Study of Doses Escalation on Efficacy on Cyberknife After Docetaxel-Cisplatin Concomitant Radiotherapy for Non Small Cells Lung Cancer Stage III
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Overall response rate by RECIST (phase II)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery after docetaxel and cisplatin may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and the best dose of stereotactic radiosurgery when given after docetaxel, cisplatin, and radiation therapy and to see how well it works in treating patients with stage III non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the maximum tolerated dose of stereotactic radiosurgery in patients with locally advanced non-small cell lung cancer undergoing concurrent chemoradiotherapy. (Phase I)
- Assess the response rate (complete and partial response) in these patients by RECIST criteria. (Phase II)
Secondary
- Determine the tolerability. (Phase I)
- Assess the quality of life of these patients by QLQ-C30 v3. (Phase I)
- Assess the overall and disease-free survival of these patients. (Phase II)
- Assess progression-free survival of these patients. (Phase II)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed non-small cell lung cancer
- •Locally advanced disease
- •No metastatic disease
- •Unable to undergo surgery after concurrent chemoradiotherapy
- •Must have 1-3 tumor target masses < 5 cm in greatest diameter and separated by ≥ 2 cm after concurrent chemoradiotherapy
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •Platelet count > 100,000/mm³
- •Hemoglobin > 9 g/dL
- •Neutrophil > 1.0 x 10^9/L
- •FEV_1 > 30% of vital capacity
- •Vital capacity > 25% of predicted value
- •DLCO > 25% of predicted value
- •LVEF ≥ 35%
- •aPTT > 35 sec
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- •Not under guardianship
- •No dyspnea related to NYHA class III-IV heart failure
- •No indirect signs of pulmonary arterial hypertension (pulmonary arterial systolic BP > 45 mm Hg)
- •No pulmonary acceleration time < 100 ms
- •No contraindication to fiducial insertion
- •No geographical, social, or psychological conditions that would interfere with medical follow-up
- •PRIOR CONCURRENT THERAPY:
- •Docetaxel and platinum-based drugs with concurrent irradiation allowed
- •No prior surgery or surgery after the first phase of treatment with concurrent chemoradiotherapy
- •No prior irradiation to lung
- •No concurrent participation in another study trial
排除标准
- 未提供
研究组 & 干预措施
CyberKnife irradiation
Experimental
干预措施: CK (Device)
结局指标
主要结局
Overall response rate by RECIST (phase II)
时间窗: 5 years
Maximum tolerated dose (phase I)
时间窗: 5 years
次要结局
未报告次要终点
研究者
研究点 (1)
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