A Prospective, Randomized, Controlled Phase Ⅱ Study of Preventively Use of Methylprednisolone After Split-course Chemoradiotherapy to Reduce the Risk of Radiation-induced Pulmonary Injury For Bulky Local Advanced None-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- rate of grade≥2 radiation pneumonia(NCI-CTC4.0)
研究概览
简要总结
This Phase II randomized controlled study is to determine the efficacy of the preventively use of methylprednisolone after split-course chemoradiotherapy (CCRT) in locally advanced non-small cell lung cancer with bulky tumor.
详细描述
This study is to determine the efficacy of the preventively use of methylprednisolone after split-course chemoradiotherapy(CCRT) in locally advanced non-small cell lung cancer with bulky tumor.
All patients received four cycles of weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡)(DP), each of 1 day's duration, combined with split-course thoracic radiotherapy, with one-month break. In the experimental arm, patients were treated with methylprednisolone after the first course of radiation, once a day, 32 milligram (mg) for 7 days, 24 mg for the next 7 days,then 16mg for 7 days, and 8 mg for the last 7 days. Toxicities will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0.
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
- •Pathologic confirmation of NSCLC.
- •Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- •Unresectable phase IIIA(N2) and IIIB lung cancer confirmed by PET/CT, CT or MRI.
- •Whole lung V20>=35% when giving 60Gy which is the minimum dose of radical irradiation.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Previously treated with chemotherapy or treatment-naive
- •No previous chest radiotherapy, immunotherapy or biotherapy
- •Hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL
- •Serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min
- •Bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL
- •FEV1 >0.8 L
- •CB6 within normal limits
- •patients and their family signed the informed consents
排除标准
- •Previous or recent another malignancy, except nonmelanoma skin cancer or cervical cancer in situ
- •Contraindication for chemotherapy
- •Malignant pleural or pericardial effusion.
- •Women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose
- •Women who has the probability of pregnancy without contraception
- •Tendency of hemorrhage
- •In other clinical trials within 30 days
- •Addicted in drugs or alcohol, AIDS patients
- •Uncontrollable seizure or psychotic patients without self-control ability
- •Severe allergy or idiosyncrasy
- •Not suitable for this study judged by researchers
研究组 & 干预措施
Methylprednisolone
Patients were treated with methylprednisolone after the first course of chest radiation and concurrent chemotherapy, once a day, 32 milligram (mg) for 7 days, 24 mg for the next 7 days, then 16mg for 7 days, and 8 mg for the last 7 days.
干预措施: chest radiation (Radiation)
Methylprednisolone
Patients were treated with methylprednisolone after the first course of chest radiation and concurrent chemotherapy, once a day, 32 milligram (mg) for 7 days, 24 mg for the next 7 days, then 16mg for 7 days, and 8 mg for the last 7 days.
干预措施: concurrent chemotherapy (Drug)
Methylprednisolone
Patients were treated with methylprednisolone after the first course of chest radiation and concurrent chemotherapy, once a day, 32 milligram (mg) for 7 days, 24 mg for the next 7 days, then 16mg for 7 days, and 8 mg for the last 7 days.
干预措施: Methylprednisolone (Drug)
Observation
Observation after the first course of chest radiation, methylprednisolone can only be used for therapeutic purpose in the presence of grade≥2 radiation induced lung injury(NCI-CTC4.0).
干预措施: chest radiation (Radiation)
Observation
Observation after the first course of chest radiation, methylprednisolone can only be used for therapeutic purpose in the presence of grade≥2 radiation induced lung injury(NCI-CTC4.0).
干预措施: concurrent chemotherapy (Drug)
结局指标
主要结局
rate of grade≥2 radiation pneumonia(NCI-CTC4.0)
时间窗: 1 year from the end of radiotherapy
radiation-induced pulmonary injury is classified into 1-5 grades according to NCI-CTC4.0. The incidence of symptomatic radiation-induced pulmonary injury: the ratio of grade 2 and above radiation-induced pulmonary injury cases in 1 year after radio therapy to all cases can be evaluated .
次要结局
- the rate of grade≥2 pulmonary ventilation and diffusion capacity decline(1 year from the end of radiotherapy)
- the rate of grade≥2 visible change in CT after radiation(1 year from the end of radiotherapy)
研究者
Hui Liu
Professor
Sun Yat-sen University