NCT00020839终止3 期
Temozolomide Versus Temozolomide + Whole Brain Radiation In Stage IV Melanoma Patients With Asymptomatic Brain Metastases
European Organisation for Research and Treatment of Cancer - EORTC33 个研究点 分布在 11 个国家目标入组 23 人开始时间: 2001年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 33
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. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if chemotherapy is more effective with or without radiation therapy in treating brain metastases.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy to the brain in treating patients who have stage IV melanoma with asymptomatic brain metastases.
详细描述
OBJECTIVES:
- Compare the efficacy of temozolomide with or without radiotherapy in terms of overall survival in patients with stage IV melanoma with asymptomatic brain metastases.
- Compare the time to appearance of neurological symptoms in patients treated with these regimens.
- Compare the progression-free survival of patients treated with these regimens.
- Compare the quality of life and quality-adjusted survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to LDH levels (less than 225 U/L vs 225 U/L or more), concurrent metastases (visceral vs soft tissue), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral temozolomide once daily on days 1-5. Treatment continues every 4 weeks for a maximum of 1 year in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive temozolomide as in arm I and whole brain radiotherapy on days 8-12 and 15-19 during the first course of chemotherapy.
Quality of life is assessed before beginning each course and then every 4 weeks after completion of study drug.
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 confirmed unresectable metastatic melanoma
- •Must have asymptomatic brain metastasis that is not amenable to surgery or stereotactic radiosurgery (gamma knife, Linac)
- •Must have concurrent visceral/soft tissue metastases
- •At least 1 site of measurable disease (not necessarily the brain metastasis)
- •Documented evidence of disease progression defined by 1 of the following conditions:
- •More than 25% increase in the size of at least 1 measurable lesion
- •Appearance of a new lesion
- •A significant increase in the size of nonmeasurable disease
- •No neurological symptoms, including signs of elevated intracranial pressure
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Bilirubin less than 1.5 times upper limit of normal (ULN)
- •SGOT or SGPT less than 3 times ULN
- •Alkaline phosphatase less than 3 times ULN
- •Urea less than 1.5 times ULN
- •Creatinine less than 1.5 times ULN
- •No frequent vomiting or medical condition (e.g., partial bowel obstruction) that would interfere with oral medication intake
- •No other prior or concurrent malignancy except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
- •No uncontrolled infection
- •HIV negative
- •No AIDS-related illness
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No psychological, familial, sociological, or geographical condition that would preclude study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Prior cytokine via isolated limb perfusion for local-regional melanoma allowed
- •No other prior cytokine for metastatic melanoma
- •No concurrent colony-stimulating factors, including epoetin alfa or filgrastim (G-CSF)
- •No other concurrent immunologic or biologic therapy
- •Chemotherapy:
- •Prior chemotherapy via isolated limb perfusion for local-regional melanoma allowed
- •No other prior chemotherapy for metastatic melanoma
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •Concurrent corticosteroids allowed during radiotherapy (arm II only)
- •No concurrent hormonal therapy
- •Radiotherapy:
- •See Disease Characteristics
- •No other concurrent radiotherapy
- •See Disease Characteristics
- 另有 2 项未显示
排除标准
- 未提供
研究者
研究点 (33)
Loading locations...
相似试验
已完成
2 期
Temozolomide in Treating Patients With Solid Tumors That Have Spread to the BrainMetastatic CancerNCT00012116Jonsson Comprehensive Cancer Center4
Unknown
2 期
Temozolomide in Treating Patients With Recurrent or Progressive Malignant GliomaBrain and Central Nervous System TumorsNCT00004204Herbert Irving Comprehensive Cancer Center
已完成
2 期
Chemotherapy and Radiation Therapy After Surgery in Treating Children With Newly Diagnosed Astrocytoma, Glioblastoma Multiforme, Gliosarcoma, or Diffuse Intrinsic Pontine GliomaBrain and Central Nervous System TumorsNCT00028795Children's Oncology Group170
已完成
2 期
Temozolomide in Treating Patients With Metastatic Non-small Cell Lung CancerLung CancerNCT00006877Case Comprehensive Cancer Center30
已完成
2 期
Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung CancerLung CancerNCT00022711Fox Chase Cancer Center7