NCT00432315已完成2 期
Multicenter Phase II Study Evaluating Docetaxel and CDDP as Induction Regimen Prior to Surgery or Radiochemotherapy With Docetaxel, Followed by Adjuvant Docetaxel Therapy in Chemonaive Patients With NSCLC Stage II, IIIa and IIIb
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To assess the response rate to induction therapy with docetaxel in combination with CDDP
研究概览
简要总结
Primary objective:
• To assess the response rate to induction therapy with docetaxel/CDDP.
Secondary objectives:
To assess
- Resectability after induction therapy
- Time to progression
- Overall survival
- Safety profile
- Quality of Life
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Histology and staging of the disease
- •Histologically or cytologically confirmed NSCLC; histology may include: large cell, squamous cell or adenocarcinoma but no SCLC
- •Resectable or unresectable NSCLC stage II (T1-2 N1, T3 N0) or stage IIIa (T1-2 N2 or T3 N1-2) or stage IIIb (T1-3 N3 or T4 N0-3)
- •Measurable disease (bidimensionally or unidimensionally according to WHO criteria)
- •General conditions
- •Karnofsky Status > 70, if age > 70 years → PS > 70
- •Adequate hematological function (Hb > 10 g/dl, ANC > 2.0 x 109/L, platelets > 100 x 109/L)
- •Adequate renal and hepatic functions: total bilirubin < 1 x upper normal limit (UNL), serum creatinine < 1 x UNL, in case of limit value the creatinine clearance should be > 60 ml/min, ASAT and ALAT < 2.5 x UNL, alkaline phosphatase < 5 x UNL.
排除标准
- •Evidence of brain metastases or other distant metastasis equivalent to stage IV disease
- •History of prior malignancies, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix or other curatively treated cancer with no evidence of disease for at least five years
- •Other serious concomitant illness or medical condition:
- •Congestive heart failure or angina pectoris, except if medically controlled, history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmia
- •History of significant neurologic or psychiatric disorders, including dementia or seizure
- •Active infection requiring i.v. Antibiotics
- •Active ulcer, unstable diabetes mellitus or other contraindications to corticotherapy
- •Hepatic function abnormality: ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL
- •Current peripheral neuropathy WHO grade > 2
- •Prior or concurrent therapy
- •Prior chemotherapy or immunotherapy for NSCLC, including neoadjuvant or adjuvant treatment
- •Prior surgery or radiotherapy for NSCLC
- •Concurrent treatment with other experimental drugs, unapproved medical procedures or other anticancer therapy
- •General conditions
- •Pregnant or lactating patients
- •Patients (M/F) with reproductive potential not implementing adequate contraceptive measurements
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
Resectable NSCLC
干预措施: docetaxel + CDDP (Drug)
2
Experimental
Unresectable NSCSC
干预措施: docetaxel + CDDP (Drug)
结局指标
主要结局
To assess the response rate to induction therapy with docetaxel in combination with CDDP
时间窗: every 3 months until tumour progression and thereafter every 6 months until death
次要结局
- Safety profile(throughout the study)
- Quality of life(every 3 months until tumour progression and thereafter every 6 months until death)
- Resectability after induction therapy(every 3 months until tumour progression and thereafter every 6 months until death)
- Time to progression(every 3 months until tumour progression and thereafter every 6 months until death)
- Overall survival(every 3 months until tumour progression and thereafter every 6 months until death)
研究者
研究点 (1)
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