A Phase II,Randomized Controlled Clinical Trial of Staged Thoracic Radiotherapy Combined With Albumin Bound Paclitaxel and Nedaplatin Twice a Week for Locally Advanced NSCLC
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- local control rate
研究概览
简要总结
This phase II randomized study is to investigate the efficacy and toxicity of fractional thoracic radiotherapy combined with albumin bound paclitaxel and nedaplatin twice a week in the treatment of locally advanced non-small cell lung cancer compared with weekly chemotherapy.
详细描述
This phase II randomized study is to investigate the efficacy and toxicity of fractional thoracic radiotherapy combined with albumin bound paclitaxel and nedaplatin twice a week in the treatment of locally advanced non-small cell lung cancer compared with weekly chemotherapy.
Radiotherapy:
All patients will receive intensity modulated radiotherapy (IMRT) once a day, 5 days a week. The first stage: DT 3000 cGy / 6 FX; the second stage, DT 3500 cGy / 7 FX. Or: the first segment: DT 4000 cGy / 10 FX; the second segment DT 2400 cGy / 6 FX. The interval between two stages of radiotherapy was 4 weeks.
Concurrent chemotherapy:
The patients were randomly divided into two groups and received one of the following concurrent chemotherapy regimens:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed non-small cell lung cancer.
- •There were measurable diseases according to recist1.
- •Non operative stage III (AJCC / UICC eighth edition stage).
- •When the lowest dose of radiotherapy was 60Gy, V20 > = 35% in both lungs.
- •18 years old or above, under 75 years old, regardless of gender.
- •ECoG physical status score (see Annex 1) was 0-
- •Initial treatment or chemotherapy.
- •There was no previous chest radiotherapy, immunotherapy or biotherapy.
- •Neutrophil absolute value ≥ 2000 cells / mm3, platelet ≥ 100000 cells / mm3
- •Serum creatinine ≤ 1.25 times ULN or creatinine clearance rate ≥ 60 ml / min.
- •Serum bilirubin ≤ 1.5 times ULN, AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN, alkaline phosphatase ≤ 5 times ULN.
- •CB6 normal range.
- •The patient and his family members agreed and signed the informed consent.
排除标准
- •There were other malignant tumors in the past or during treatment, except for skin non melanoma or cervical carcinoma in situ.
- •Any other disease or condition is contraindication to chemotherapy (e.g. active infection, within 6 months after myocardial infarction, symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy).
- •Pregnant or lactating women, women who did not undergo a pregnancy test (within 14 days before the first administration), and pregnant women.
- •Bleeding tendency.
- •Participants in other clinical trials within 30 days before the experiment.
- •Drug addiction, long-term alcoholism and AIDS patients.
- •There are uncontrollable seizures or loss of self-control due to mental illness.
- •Patients with severe allergic history or specific constitution.
- •The researchers consider that it is not suitable to participate in this experiment.
研究组 & 干预措施
Concurrent chemotherapy Twice a Week
During the period of radiotherapy, 30 mg / m2 albumin bound paclitaxel was intravenously infused twice a week for 0.5 hours, and nedaplatin 10 mg / m2 twice a week for 0.5 hours.
干预措施: chest radiation(IMRT) (Radiation)
Concurrent chemotherapy Twice a Week
During the period of radiotherapy, 30 mg / m2 albumin bound paclitaxel was intravenously infused twice a week for 0.5 hours, and nedaplatin 10 mg / m2 twice a week for 0.5 hours.
干预措施: Concurrent chemotherapy twice a week (Drug)
Concurrent chemotherapy Once a Week
During the same period of radiotherapy, albumin bound paclitaxel (50 mg / m2) was intravenously infused once a week for 0.5 hours; nedaplatin (25 mg / m2) was intravenously infused once a week for 0.5 hours.
干预措施: chest radiation(IMRT) (Radiation)
Concurrent chemotherapy Once a Week
During the same period of radiotherapy, albumin bound paclitaxel (50 mg / m2) was intravenously infused once a week for 0.5 hours; nedaplatin (25 mg / m2) was intravenously infused once a week for 0.5 hours.
干预措施: Concurrent chemotherapy once a week (Drug)
结局指标
主要结局
local control rate
时间窗: 2 years
To assess the efficacy of albumin bound paclitaxel twice a week in terms of local control rate for all patients
次要结局
- Progression-free Survival(2 Years)
- Overall Survival(OS)(2 Years)
- rate of grade 3-4 radiation pneumonitis(1 year)
- Response Rate(RR)(2 years)
- Distant metastasis rate(2 years)
- rate of grade 3-4 radiation esophagitis(1 year)
研究者
Hui Liu
Professor
Sun Yat-sen University