A Phase II Trial of Combined Modality Therapy With Growth Factor Support for Patients With Limited Stage Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 14
- 主要终点
- Number of Patients With Grade 3-4 Febrile Neutropenia During Concurrent Chemoradiotherapy
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Colony-stimulating factors, such as G-CSF or pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy and radiation therapy.
PURPOSE: This phase II trial is studying G-CSF and pegfilgrastim to see how well they work in treating neutropenia in patients undergoing combination chemotherapy and radiation therapy for limited stage small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To evaluate the safety and efficacy of filgrastim (G-CSF) in reducing grade 4 neutropenia or grades 3-4 febrile neutropenia in patients with limited stage small cell lung cancer treated with radiotherapy and concurrent chemotherapy comprising cisplatin and etoposide.
Secondary
- To evaluate the safety and efficacy of pegfilgrastim in reducing grade 4 neutropenia or grades 3-4 febrile neutropenia in patients treated with adjuvant chemotherapy comprising cisplatin and etoposide.
- To estimate the incidence of dose modifications or treatment delays in patients treated with this regimen.
- To estimate the incidence of esophagitis, pneumonitis, and other non-hematological adverse events in patients treated with this regimen.
- To estimate the incidence of grade 4 thrombocytopenia in patients treated with this regimen.
- To estimate the median and two-year rate of progression-free and overall survival of patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Combined Modality Therapy with Growth Factor Support
Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim.
干预措施: Filgrastim (Drug)
Combined Modality Therapy with Growth Factor Support
Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim.
干预措施: Pegfilgrastim (Drug)
Combined Modality Therapy with Growth Factor Support
Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim.
干预措施: Etoposide (Drug)
Combined Modality Therapy with Growth Factor Support
Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim.
干预措施: Cisplatin (Drug)
Combined Modality Therapy with Growth Factor Support
Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim.
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Number of Patients With Grade 3-4 Febrile Neutropenia During Concurrent Chemoradiotherapy
时间窗: From start of treatment to end of concurrent chemoradiation, for a maximum of 45 days
Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. No testing was done due to early study termination.
次要结局
- Progression-free Survival(From registration to last follow-up, a maximum of 32.9 months)
- Number of Patients With Grade 4 Thrombocytopenia(From registration to last follow-up, a maximum of 32.9 months)
- Number of Patients With Grade 3-4 Febrile Neutropenia During Adjuvant Chemoradiotherapy(From the start to the end of adjuvant chemotherapy, a maximum of 24 days)
- Number of Patients With Dose Modifications or Treatment Delays(From start of treatment to end of treatment, for a maximum of 66 days)
- Overall Survival(From registration to last follow-up, a maximum of 32.9 months)
- Number of Patients With Grade 3+ Esophagitis, Pneumonitis, and Other Non-hematological Adverse Events(From registration to last follow-up, a maximum of 32.9 months)