NCT00091572已完成3 期
Extended Schedule, Escalated Dose Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 859
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this study is to ascertain if the extended schedule of Temozolomide, which allows increased doses and potential depletion of the enzyme underlaying resistance, is a more effective treatment of metastatic melanoma than single agent dacarbazine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Histologically confirmed, stage IV, surgically incurable melanoma
- •Age 18 years or older
- •World Health Organization (WHO) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Meets protocol requirements for specified laboratory values
- •Must be able to take oral medication
- •Must be disease free from cancer for period of 5 years (except for surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin).
- •Women of childbearing potential and men must be practicing a medically approved contraception.
- •Must provide written informed-consent to participate in the study.
- •Must have full recovery from major surgery or adjuvant treatment
- •No clinically uncontrolled infectious disease including HIV or AIDS-related illness
排除标准
- •Ocular melanomas
- •Brain Metastases
- •Prior cytokine or chemotherapy for stage IV disease
- •Pregnant or nursing women
研究组 & 干预措施
A
Experimental
temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
干预措施: Temozolomide (Drug)
B
Active Comparator
dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
干预措施: Dacarbazine (Drug)
结局指标
主要结局
Overall Survival
时间窗: The final analysis was to be performed when at least 616 deaths had occurred.
Overall Survival was defined as the time from the date of randomization to the date of death from any cause.
次要结局
- Progression Free Survival(Treatment continued until disease progression or unacceptable toxicity. Patients will be followed for survival.)
- Objective Response Rate in Subjects With Measurable Lesions(Treatment continued until disease progression or unacceptable toxicity.)
- Duration of Objective Response(Treatment continued until disease progression or unacceptable toxicity.)
研究者
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