Hypofractionated Radiotherapy Followed by Hypofractionated Boost With Weekly Concurrent Chemotherapy for Unresectable Stage III Non-Small Cell Lung Cancer: A Prospective, Single Arm Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
The primary objective is to assess the safety and efficacy of hypofractionated radiotherapy followed by hypo-boost combined with concurrent weekly chemotherapy in unresectable LA-NSCLC patients.
详细描述
Patients receive four cycles of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration, concurrent with split-course thoracic radiotherapy of 40 Gy/10 fractions and 28 Gy/7 fractions administered in the first and second courses, respectively, with one-month break. The primary end point is progression-free survival, which is the time that passes from the first day of radiotherapy to the date at which disease progresses. Progression-free survival will be calculated using the Kaplan-Meier method.Toxicities will be graded according to CTCAE v. 4.0.
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 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
split-course radiotherapy
The radiotherapy is delivered using simultaneous integrated boost (SIB)-intensity-modulated radiotherapy (IMRT). Patients are irradiation at a palliative dose at the initial course: 40Gy/10f to gross tumor. The disease is re-evaluated one month after the end of the initial course using CT. The patient who achieved a partial remission according to the RECIST criteria and had a recovery of lung function should get the additional boost. At the second course, the tumor is re-simulated. The residual tumor was then treated with the second course of radiotherapy. A dose of 28Gy/7f is delivered to the residue tumor. Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.
干预措施: split-course radiotherapy (Radiation)
split-course radiotherapy
The radiotherapy is delivered using simultaneous integrated boost (SIB)-intensity-modulated radiotherapy (IMRT). Patients are irradiation at a palliative dose at the initial course: 40Gy/10f to gross tumor. The disease is re-evaluated one month after the end of the initial course using CT. The patient who achieved a partial remission according to the RECIST criteria and had a recovery of lung function should get the additional boost. At the second course, the tumor is re-simulated. The residual tumor was then treated with the second course of radiotherapy. A dose of 28Gy/7f is delivered to the residue tumor. Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.
干预措施: concurrent chemotherapy (Drug)
结局指标
主要结局
progression-free survival
时间窗: 3 years
次要结局
- response rate(2 months)
- rate of grade 3-4 radiation esophagitis(1 year)
- overall survival(3 years)
- rate of grade 3-4 radiation pneumonitis(1 year)
研究者
Hui Liu
Professor
Sun Yat-sen University