Multicenter Randomized Phase III Study Comparing Fixed Doses Versus Toxicity Adjusted Dosing of Cisplatin and Etoposide for Patients With Small Cell Lung Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
- 试验地点
- 12
- 主要终点
- objective response
研究概览
简要总结
The purpose of this study is to compare the activity of fixed doses of cisplatin and etoposide with toxicity adjusted dosing of the same drugs in the first-line treatment of small cell lung cancer.
详细描述
The standard treatment for advanced small cell lung cancer (SCLC) is combination chemotherapy of cisplatin or carboplatin with etoposide. Standard fixed doses of this combination have been based on calculating a patient's body surface area. This method of dose calculation has been shown to be poorly correlated with the activity of many chemotherapy drugs, and some patients do not obtain adequate levels of the drug in their circulation. Recent reports suggest that patients who have a very high tolerability to chemotherapy (without significant toxicity), are at risk for having less effectiveness of the therapy. This study will compare fixed doses of standard chemotherapy with a new strategy of the same chemotherapy with doses that will be adjusted according to the toxicity observed.
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
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cytologic or histologic diagnosis of small cell lung cancer
- •Extensive disease according to VALG classification
- •One or more target lesions.
- •Performance status (ECOG) 0 or 1
- •Age <70 years.
- •Patients with asymptomatic cerebral metastases are eligible
- •Patients who have completed treatment with radiation therapy at least 4 weeks prior to enrollment are eligible
- •Written informed consent
排除标准
- •Previous chemotherapy
- •Previous or concomitant malignant neoplasm (excluding adequately treated baso or spinocellular skin carcinoma or carcinoma in situ of the cervix)
- •Neutrophil < 2000/mm3, platelets < 100,000/mm3, haemoglobin < 10 g/dl
- •Creatinine > 1.5 x the upper normal limits
- •GOT and/or GPT > 2.5 and/or Bilirubin > 1.5 times the upper normal limits in absence of hepatic metastases
- •GOT and/or GPT > 5 and/or Bilirubin > 3 times the upper normal limits in presence of hepatic metastases
- •Any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study
- •Hypersensitivity to darbepoetin alpha, to r-HuEPO or their components
- •Uncontrolled hypertension.
- •Inability to provide informed consent.
- •Inability to comply with follow-up
研究组 & 干预措施
A
standard fixed doses
干预措施: cisplatin (Drug)
A
standard fixed doses
干预措施: etoposide (Drug)
B
toxicity adjusted dosing
干预措施: cisplatin (Drug)
B
toxicity adjusted dosing
干预措施: etoposide (Drug)
结局指标
主要结局
objective response
时间窗: after 3 and 6 cycles of chemotherapy
次要结局
- toxicity(during and after each treatment cycle)