Concurrent Nab--paclitaxel/Carboplatin and Thoracic Radiotherapy in Inoperable Stage III Squamous Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- PFS (progression-free survival )
研究概览
简要总结
Nab-paclitaxel and carboplatin showed better treatment response compared with cremophor-based paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer, especially for squamous cell cancer. This study is conducted to evaluate the efficacy and safety of nab-paclitaxel, carboplatin and concurrent radiotherapy in patients with local advanced inoperable squamous cell lung cancer.
详细描述
This study was conducted to explore the efficacy and safety of concurrent concurrent nab-paclitaxel, carboplatin and thoracic radiotherapy in inoperable local advanced squamous cell lung cancer. Patients will be given nab-paclitaxel weekly at a dose of 40mg/m2, in combination with carboplatin (AUC 2) weekly during concurrent chemoradiotherapy. Thoracic radiation was administered at a dose of 60-66 Gy/30-33 fractions, both 3 dimensional conformal and intensity modulated radiation therapy are allowed.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 Years to 70 Years
- •Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
- •Previously untreated, histological documented, inoperable stage III squamous cell carcinoma of lung, excluding those with pericardial, pleural effusion, and those with contralateral hilar or contralateral supraclavicular lymph nodes.
- •Patients must have measurable disease according to RECIST criteria, and all detectable tumor can be encompassed by radiation therapy fields.
- •Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.
- •Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
- •Patients must sign a study-specific informed consent form prior to study entry.
排除标准
- •Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
- •Previous chemotherapy or previous biologic response modifiers for current lung cancer.
- •Patient has previously had thoracic radiation therapy.
- •Prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for five years or more.
- •Serious concomitant disorders that would compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator.
- •History of significant neurological or mental disorder, including seizures or dementia.
研究组 & 干预措施
Nab-paclitaxel
Nab-paclitaxel and carboplatin for Injection; thoracic radiation therapy
干预措施: Nab-paclitaxel (Drug)
Nab-paclitaxel
Nab-paclitaxel and carboplatin for Injection; thoracic radiation therapy
干预措施: Carboplatin (Drug)
Nab-paclitaxel
Nab-paclitaxel and carboplatin for Injection; thoracic radiation therapy
干预措施: Thoracic radiation therapy (Radiation)
结局指标
主要结局
PFS (progression-free survival )
时间窗: 5 years from patient enrollment
PFS is defined as time from the start of treatment to death, progression of disease, or the last follow-up data, whichever comes first. Progression is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. PFS will be analyzed using the Kaplan-Meier method.
次要结局
- OS (Overall survival)(5 years from patient enrollment)
- Number of participants with adverse events as assessed by CTCAE v4.0(5 years from patient enrollment)
- ORR (Overall Response Rate )(one month after the end of all treatment)
- Patient quality of life (QOL)(5 years from patient enrollment)
- LCR (Local Control Rate)(one month after the end of all treatment)
研究者
Conghua Xie,MD,PhD
director of Department of Radiation and Medical Oncology, Zhongnan Hospital
Wuhan University