Phase III Randomized Trial of Sequential High-Dose Chemotherapy Versus Standard Chemotherapy for the Treatment of Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 430
- 试验地点
- 2
- 主要终点
- Overall survival (OS) at 3 years
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy with peripheral stem cell transplant or bone marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known whether high-dose chemotherapy plus peripheral stem cell or bone marrow transplant is more effective than chemotherapy alone in treating small cell lung cancer.
PURPOSE: This randomized phase III trial is studying how well chemotherapy followed by peripheral stem cell or bone marrow transplant works compared to chemotherapy alone in treating patients with limited-stage or extensive-stage small cell lung cancer.
详细描述
OBJECTIVES:
- Compare the overall survival of patients with limited or extensive stage small cell lung cancer treated with sequential high-dose ifosfamide, carboplatin, and etoposide phosphate followed by autologous peripheral blood stem cell or bone marrow transplantation versus standard ifosfamide, carboplatin, and etoposide.
- Compare the progression-free survival, time to treatment failure, and response rate in patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (limited disease vs extensive disease with vs without liver metastases), performance status (0 vs 1), gender, LDH level (normal vs abnormal), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive induction therapy comprising epirubicin IV over 4 hours on day 1 and paclitaxel IV over 3 hours on day 2. Treatment repeats every 21 days for a total of 2 courses. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 3 and continuing for 10 days or during course 2 until peripheral blood stem cell (PBSC) collection is completed. After completion of induction chemotherapy, autologous PBSCs or bone marrow is collected.
Within 28 days of the start of the second course of induction chemotherapy, patients receive high-dose ifosfamide IV over 17 hours, carboplatin IV over 3 hours, and etoposide phosphate IV over 3 hours on days 1-4. At 48 hours after completion of high-dose chemotherapy, patients undergo autologous PBSC or bone marrow transplantation and then receive G-CSF SC for 14 days. Treatment repeats every 28 days for 3 courses.
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
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed small cell lung cancer
- •Limited disease or extensive disease with no more than 2 metastatic sites
- •No CNS metastasis
- •PATIENT CHARACTERISTICS:
- •65 and under
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,500/mm^3 OR
- •Platelet count greater than 100,000/mm^3 OR
- •Hemoglobin at least 10.0 g/dL
- •AST/ALT less than 2.5 times upper limit of normal (ULN)
- •Alkaline phosphatase less than 2.5 times ULN
- •Bilirubin less than 2.5 times ULN
- •Creatinine clearance at least 60 mL/min
- •No renal function that would preclude chemotherapy
- •Cardiovascular:
- •No congestive heart failure
- •LVEF at least 50%
- •No cardiac function that would preclude chemotherapy
- •No other malignancy within the past 3 years except for basal cell skin cancer or carcinoma in situ of the cervix
- •No psychiatric disorder or any other disorder that would preclude study participation
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Overall survival (OS) at 3 years
次要结局
- Progression-free survival (PFS) at 3 years
- Toxicity at 3 years
- Quality of life (QOL) at 3 years