NCT00072124已完成3 期
A Prospective Random Assignment Trial Comparing Complete Metastasectomy to Chemotherapy for Selected Patients With Stage IV Melanoma
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as dacarbazine and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Complete metastasectomy may be an effective treatment for metastatic melanoma and may improve quality of life and help patients live longer and more comfortably. It is not yet known whether complete metastasectomy is more effective than chemotherapy in treating stage IV melanoma.
PURPOSE: This randomized phase III trial is studying dacarbazine and/or cisplatin to see how well they work compared to complete metastasectomy in treating patients with stage IV melanoma.
详细描述
OBJECTIVES:
Primary
- Compare overall survival in patients with stage IV melanoma treated with complete metastasectomy vs dacarbazine and/or cisplatin.
Secondary
- Compare time to progression in patients treated with these regimens.
- Determine the response rate in patients treated with dacarbazine and/or cisplatin.
- Compare the morbidity and quality of life of patients treated with these regimens.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of metastatic melanoma
- •Solitary pulmonary nodule may not be sole site of metastatic disease
- •No disease limited to subcutaneous, cutaneous, or peripheral nodal (neck, axillary, groin, or iliac nodes) sites only
- •Measurable disease
- •Disease progression during or after prior interleukin-2 (IL-2)-based therapy OR ineligible for high-dose IL-2 therapy
- •Metastatic disease amenable to complete surgical resection
- •Less than 5% estimated mortality from surgery
- •Prior complete metastasectomy allowed provided disease did not recur within 6 months after surgery
- •No primary ocular or mucosal melanoma
- •No brain metastases
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Performance status
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •WBC at least 3,000/mm^3 OR
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •No coagulation disorder
- •Hepatitis B surface antigen negative
- •Hepatitis C antibody negative
- •Creatinine no greater than 1.6 mg/dL OR
- •Creatinine clearance at least 70 mL/min
- •No major medical illness of the renal system
- •Cardiovascular
- •No major medical illness of the cardiovascular system
- •No major medical illness of the respiratory system
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •No active systemic infection
- •No form of primary or secondary immunodeficiency
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No concurrent palliative radiotherapy
- •See Disease Characteristics
- •No concurrent palliative surgery
- •More than 3 weeks since prior therapy for melanoma (except surgery)
- •No other concurrent therapy for melanoma
排除标准
- 未提供
研究者
研究点 (2)
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