Sequential Administration of Docetaxel/Gemcitabine Followed by Concurrent Chemo-radiotherapy, With or Without Consolidation Chemotherapy, as First Line Treatment in Patients With Unresectable Stage IIIA/IIIB NSCLC. A Randomized Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 38
- 试验地点
- 10
- 主要终点
- Time to tumor progression (TTP)
研究概览
简要总结
The combination of chemotherapy with radiotherapy remains the standard of therapy for patients with stage III NSCLC. A recent phase II study has presented encouraging data regarding the administration of docetaxel as consolidation treatment after definitive concurrent chemo-radiotherapy.
详细描述
To evaluate whether the administration of consolidation therapy with docetaxel/carboplatin after induction chemotherapy followed by concurrent chemoradiotherapy, offers any advantage regarding time to tumor progression
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically or cytologically confirmed, unresectable locally advanced (stage IIIA/IIIB) NSCLC
- •no previous therapy for NSCLC is allowed
- •age >18 years
- •bidimensionally measurable disease
- •performance status (WHO) 0-2
- •absence of pleural effusion
- •adequate liver (serum bilirubin < 1.5 times the upper normal limit (UNL); AST and ALT < 2.5 times the UNL in the absence of demonstrable liver metastases, or < 5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine < 1.5 times the UNL); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
- •life expectancy of more than 3 months
- •written informed consent
排除标准
- •active infection
- •history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
- •malnutrition (loss of ≥ 20% of the original body weight)
- •performance status: 3-4
- •sensor or motor neuropathy > grade I
- •second primary malignancy, except for non-melanoma skin cancer
- •psychiatric illness or social situation that would preclude study compliance
- •pregnant or lactating women
研究组 & 干预措施
1
DG -> RT
干预措施: Docetaxel (Drug)
1
DG -> RT
干预措施: Gemcitabine (Drug)
1
DG -> RT
干预措施: Chemoradiotherapy (Radiation)
2
DG -> RT -> DCarbo
干预措施: Docetaxel (Drug)
2
DG -> RT -> DCarbo
干预措施: Gemcitabine (Drug)
2
DG -> RT -> DCarbo
干预措施: Carboplatin (Drug)
2
DG -> RT -> DCarbo
干预措施: Chemoradiotherapy (Radiation)
结局指标
主要结局
Time to tumor progression (TTP)
时间窗: 1 year
次要结局
- Response rate(Objective responses confirmed by CT or MRI (on 3rd and 6th cycle))
- Overall survival(Probability of 1-year survival (%))
- Toxicity(Toxicity assessment on each chemotherapy cycle)
- Symptom improvement(Assessment every two cycles)
- Quality of life(Assessment every two cycles)