NCT00112710Unknown3 期
A British Thoracic Oncology Group Phase III Trial of Gemcitabine Plus Cisplatin at 80mg/m Versus Gemcitabine Plus Carboplatin At 50 mg/m Versus Gemcitabine Plus Carboplatin AUC 6 in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)
University Hospital Birmingham4 个研究点 分布在 1 个国家目标入组 1,350 人开始时间: 2005年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 1,350
- 试验地点
- 4
- 主要终点
- Length of survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving gemcitabine together with cisplatin is more effective than giving gemcitabine together with carboplatin in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine and carboplatin in treating patients with stage III or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Compare the efficacy of gemcitabine in combination with 2 different doses of cisplatin vs carboplatin, in terms of survival time, in patients with stage IIIB or IV non-small cell lung cancer.
Secondary
- Compare symptom control and quality of life of patients treated with these regimens.
- Compare response in patients treated with these regimens.
- Compare the dose intensity of these regimens in these patients.
- Compare the ratio of courses of treatment given as in-patient vs out-patient in these patients.
- Compare the intensity and number and duration of toxic episodes in patients treated with these regimens.
- Compare cost and cost-effectiveness of these regimens in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria:
- •Stage IIIB disease* that is not suitable for radical radiotherapy
- •Stage IV disease* NOTE: *Radiographically verified
- •At least 1 measurable lesion by clinical examination or radiography
- •No mixed histologies of small cell lung cancer and NSCLC
- •No clinically apparent brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •WBC ≥ 3,000/mm³
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 10 g/dL
- •AST < 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- •Alkaline phosphatase < 3 times ULN
- •Bilirubin < 1.5 times ULN
- •Creatinine clearance ≥ 60 mL/min (by Wright equation) OR ≥ 70 mL/min (by ^51Cr-EDTA clearance)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Able and willing to participate in the quality of life assessment
- •No pre-existing neuropathy > grade 2
- •No other malignancy that would preclude study treatment or study comparisons
- •No evidence of severe or uncontrolled systemic disease, significant clinical disorder, or laboratory finding that would preclude study participation
- •No psychiatric disorder that would preclude study participation
- •No other condition that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent immunotherapy
- •Chemotherapy
- •No prior chemotherapy, including neoadjuvant or adjuvant chemotherapy
- •No other concurrent cytotoxic chemotherapy
- •Endocrine therapy
- •No concurrent hormonal therapy except contraceptives or replacement steroids
- •Radiotherapy
- •No prior radiotherapy
- •Recovered from prior surgery
- •Prior surgical resection for NSCLC allowed
- •More than 12 weeks since prior investigational agents and recovered
- •No other concurrent specific antitumor therapy
- •No other concurrent investigational agents
排除标准
- 未提供
结局指标
主要结局
Length of survival
次要结局
- Symptom control and quality of life as measured by the EORTC Quality of Life Questionnaire Core 30 Items and Lung Cancer supplement 13 together with EuroQol-5 domain questionnaire
- Treatment response as measured by RECIST criteria
- Dose intensity of chemotherapy
- Ratio of treatment courses given as in-patient versus out-patient
- Toxicity as measured by CTCAE v3.0
- Treatment cost
研究者
研究点 (4)
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