Phase II Trial Evaluating Resection Followed By Adjuvant Radiation Therapy (RT) For Patients With Desmoplastic Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 78
- 主要终点
- 2-year Local Recurrence Rate (LRR)/Incidence of Local Recurrence
研究概览
简要总结
This phase II trial is studying how well adjuvant radiation therapy works in treating patients who have undergone surgery for desmoplastic melanoma. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy after surgery may kill any tumor cells remaining after surgery.
详细描述
PRIMARY OBJECTIVES:
I. Assess the recurrence rates in patients with desmoplastic melanoma (DM) >= 1 mm deep treated with adjuvant radiotherapy after surgical resection.
II. Assess recurrence rates in patients with locally recurrent DM treated with adjuvant radiotherapy after surgical resection.
SECONDARY OBJECTIVES:
I. Evaluate the impact of adjuvant radiation therapy after surgical resection on disease free and overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
2-year Local Recurrence Rate (LRR)/Incidence of Local Recurrence
时间窗: Within 2 years after treatment
The primary endpoint is the incidence of local recurrence within 2 years after treatment. Local recurrence (LR) is defined as a desmoplastic melanoma lesion recurring within the radiated field. The properties of the binomial distribution will be used to construct a 95% confidence interval for the true 2-year local recurrence rate (LRR). The Kaplan-Meier method will be used if some patients are lost to follow-up.
次要结局
- Incidence of Regional and Systemic Metastases(Up to 5 years)
- Failure Time(Time from randomization to death due to any cause or disease progression (up to 5 years))
- Toxicity(Up to 5 years)
- Change in Fatigue From Baseline to 3 Months as Assessed by the Brief Fatigue Inventory(Baseline to up to 3 months)
- Survival Time(up to 5 years)