Phase II Study of Concurrent Chemoradiotherapy Using IMRT (With Single Photon Emission Computed Tomography/SPECT-CT to Define Functional Lung Volume and Positron Emission Tomography/PET to Define Gross Tumour Volume/GTV) and Docetaxel-cisplatin (or Carboplatin) Followed by Adjuvant Chemotherapy for Inoperable Stage III Non-small-cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Response rate (by contrast CT scan)
研究概览
简要总结
Primary Objective:
- Response rate (by contrast CT scan)
Secondary Objectives:
- Progression-free survival (PFS)
- Overall survival (OS)
详细描述
The duration of the study for each patient will include an up to 6-week screening phase, 12 weeks treatment phase (including a resting period of 2 weeks) followed by a long-term follow-up.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
IMRT & docetaxel-cisplatin
Concurrent chemo-RT:
Radiotherapy: IMRT - Docetaxel 20mg/m2 + cisplatin 20mg/m2 weekly for 6 weeks -
Resting period: 2 weeks -
Adjuvant chemotherapy: Q3W for 2 cycles Docetaxel 35 mg/m² IV infusion for 1 hour on D1&8 - Cisplatin 35 mg/m² on D1&8 -
Dexamethasone for a total of 3 doses is to be given at a dose of 4 mg at 12 hours, 1 hour before and 12 hours after docetaxel administration
干预措施: DOCETAXEL (Drug)
IMRT & docetaxel-cisplatin
Concurrent chemo-RT:
Radiotherapy: IMRT - Docetaxel 20mg/m2 + cisplatin 20mg/m2 weekly for 6 weeks -
Resting period: 2 weeks -
Adjuvant chemotherapy: Q3W for 2 cycles Docetaxel 35 mg/m² IV infusion for 1 hour on D1&8 - Cisplatin 35 mg/m² on D1&8 -
Dexamethasone for a total of 3 doses is to be given at a dose of 4 mg at 12 hours, 1 hour before and 12 hours after docetaxel administration
干预措施: Intensity Modulated Radiotherapy (IMRT) (Radiation)
IMRT & docetaxel-cisplatin
Concurrent chemo-RT:
Radiotherapy: IMRT - Docetaxel 20mg/m2 + cisplatin 20mg/m2 weekly for 6 weeks -
Resting period: 2 weeks -
Adjuvant chemotherapy: Q3W for 2 cycles Docetaxel 35 mg/m² IV infusion for 1 hour on D1&8 - Cisplatin 35 mg/m² on D1&8 -
Dexamethasone for a total of 3 doses is to be given at a dose of 4 mg at 12 hours, 1 hour before and 12 hours after docetaxel administration
干预措施: CISPLATIN (Drug)
结局指标
主要结局
Response rate (by contrast CT scan)
时间窗: 12 weeks after completion of adjuvant chemotherapy or within 4 weeks after premature study discontinuation
次要结局
- Progression Free survival (PFS)(Day 1 of treatment to the date of objective disease progression)
- Overall survival (OS)(Day 1 of treatment to the date of death due to any cause)
- Adverse events (including oesophageal and pulmonary toxicities)(Informed consent signature up to 12 weeks after completion of treatment)