Recombinant Human Endostatin (Endostar) Combined With Concurrent Chemoradiotherapy for Advanced Non-small Cell Lung Cancer: A Multicenter, Randomized, Controlled Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 318
- 试验地点
- 1
- 主要终点
- progression free survival (PFS)
研究概览
简要总结
To investigate the safety and efficacy recombinant human endostatin(endostar) durative transfusion combined with cocurrent chemoradiotherapy in advanced non-small cell lung cancer(NSCLC).
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
- Triple (Participant, Care Provider, Investigator)
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
- •Male or female patients, age: 18-70 years of age
- •Pathology was diagnosed as non-small cell lung cancer. According to the Tumor Node Metastasis（TNM）stage of the 8th edition of the International Association for the Study of Lung Cancer in 2017, And the pathological stage was identified as stage IIIa-b.
- •No previous chest radiotherapy and radiotherapy, immunotherapy or biological therapy.
- •Eastern Cooperative Oncology Group (ECOG) test scored 0-
- •Serum hemoglobin ≥ 100g/L, platelet ≥ 100 × 109/L, absolute number of neutrophils ≥ 1.5 × 109/L.
- •Serum creatinine ≤ 1.25 times the upper limit of normal(UNL) or creatinine clearance ≥ 60 mL/min.
- •Serum bilirubin ≤ 1.5 times UNL, Aspartate aminotransferase (AST) and adenosine triphosphate (ALT) ≤ 2.5 times UNL, alkaline phosphatase ≤ 5 times UNL.
- •Forced vital capacity rate of one second（FEV1）>0.8 litre.
- •Coagulation function is normal
- •lesions are measurable according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST1.1)standard
- •Sign the inform consent form with good compliance
排除标准
- •Carcinoid or small cell lung cancer
- •Patients with any distant metastasis
- •patients with previous or current malignancy, except for skin non-melanoma or carcinoma in situ in the cervix
- •Any other disease or condition is a contraindication to chemoradiation (eg, active infection, 6 months after myocardial infarction, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy).
- •Pregnancy or breastfeeding women
- •Women who may be pregnant but are unwilling to take appropriate contraception
- •Hereditary bleeding or coagulopathy
研究组 & 干预措施
concurrent chemoradiotherapy (CCRT)
Chemotherapy: Cisplatin (50 mg/m2) on days 1, 8, 29, and 36 and etoposide (50mg/m2) on days 1～5 and 29～33.
Radiotherapy: Thoracic radiotherapy (TRT) started with a linear accelerator (6MV-X) on the first day of chemotherapy.A minimum dose of 60 Gy (2 Gy per fraction, Monday～Friday) was delivered, and a range of 60-66 Gy in 2 Gy fractions was allowed.
干预措施: concurrent chemoradiotherapy (CCRT) (Combination Product)
W1-CCRT
Endostar(15 mg/m2) was durative transfused every 24 hours for 5 days during the normalization window of the first chemoradiotherapy cycle(days -5～-1).
Chemotherapy: Cisplatin (50 mg/m2) on days 1, 8, 29, and 36 and etoposide (50mg/m2) on days 1～5 and 29～33.
Radiotherapy: Thoracic radiotherapy (TRT) started with a linear accelerator (6MV-X) on the first day of chemotherapy.A minimum dose of 60 Gy (2 Gy per fraction, Monday～Friday) was delivered, and a range of 60-66 Gy in 2 Gy fractions was allowed.
干预措施: concurrent chemoradiotherapy (CCRT) (Combination Product)
W1-CCRT
Endostar(15 mg/m2) was durative transfused every 24 hours for 5 days during the normalization window of the first chemoradiotherapy cycle(days -5～-1).
Chemotherapy: Cisplatin (50 mg/m2) on days 1, 8, 29, and 36 and etoposide (50mg/m2) on days 1～5 and 29～33.
Radiotherapy: Thoracic radiotherapy (TRT) started with a linear accelerator (6MV-X) on the first day of chemotherapy.A minimum dose of 60 Gy (2 Gy per fraction, Monday～Friday) was delivered, and a range of 60-66 Gy in 2 Gy fractions was allowed.
干预措施: Endostar for one cycle (Drug)
W2-CCRT
Endostar(15 mg/m2) was durative transfused every 24 hours for 5 days during the normalization window of the first and the second chemoradiotherapy cycles(days -5～-1 and 24～28).
Chemotherapy: Cisplatin (50 mg/m2) on days 1, 8, 29, and 36 and etoposide (50mg/m2) on days 1～5 and 29～33.
Radiotherapy: Thoracic radiotherapy (TRT) started with a linear accelerator (6MV-X) on the first day of chemotherapy.A minimum dose of 60 Gy (2 Gy per fraction, Monday～Friday) was delivered, and a range of 60-66 Gy in 2 Gy fractions was allowed.
干预措施: concurrent chemoradiotherapy (CCRT) (Combination Product)
W2-CCRT
Endostar(15 mg/m2) was durative transfused every 24 hours for 5 days during the normalization window of the first and the second chemoradiotherapy cycles(days -5～-1 and 24～28).
Chemotherapy: Cisplatin (50 mg/m2) on days 1, 8, 29, and 36 and etoposide (50mg/m2) on days 1～5 and 29～33.
Radiotherapy: Thoracic radiotherapy (TRT) started with a linear accelerator (6MV-X) on the first day of chemotherapy.A minimum dose of 60 Gy (2 Gy per fraction, Monday～Friday) was delivered, and a range of 60-66 Gy in 2 Gy fractions was allowed.
干预措施: Endostar for two cycles (Drug)
结局指标
主要结局
progression free survival (PFS)
时间窗: 4 years
Evaluate the effect of chemoradiotherapy with or without recombinant human endostatin on progression free survival
次要结局
- Overall Survival(OS)(4 years)
- Treatment-related toxicity(4 years)
研究者
DaiYuan Ma
Director of Cancer Center
Affiliated Hospital of North Sichuan Medical College