A Phase II Efficacy Study of Chemo-Radiotherapy in PET Stage II and III Merkel Cell Carcinoma of the Skin
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 13
- 主要终点
- Time to loco-regional failure curve
研究概览
简要总结
A Phase II Study designed to evaluate the efficacy of Chemo-Radiotherapy in achieving loco-regional control in patients with Merkel Cell Carcinoma (MCC) of the skin. Patients will undergo PET scans to assist in staging and planning the patient's treatment as well as assessing response at the conclusion of treatment.
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
研究组 & 干预措施
Arm A
Conventional radical radiotherapy in this trial means that those patients with microscopic disease receive a dose of 50Gy using daily incremental fractions of 2Gy over 25 fractions and those with macroscopic disease receive 54Gy in 27 fractions.
干预措施: Carboplatin (Drug)
Arm A
Conventional radical radiotherapy in this trial means that those patients with microscopic disease receive a dose of 50Gy using daily incremental fractions of 2Gy over 25 fractions and those with macroscopic disease receive 54Gy in 27 fractions.
干预措施: Etoposide (Drug)
Arm A
Conventional radical radiotherapy in this trial means that those patients with microscopic disease receive a dose of 50Gy using daily incremental fractions of 2Gy over 25 fractions and those with macroscopic disease receive 54Gy in 27 fractions.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Time to loco-regional failure curve
时间窗: Minimum of 18 months follow up
Incidence of grade 3 and 4 toxicity and incidence of febrile neutropenia
时间窗: Duration of Radiotherapy treatment
次要结局
- Overall survival and time to distant failure curves(3 year acturarial curves)
- Proportion of patients for which PET can influence management.(12 weeks post Radiotherapy)
- Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of PET.(12 weeks post Radiotherapy)
- Post-treatment PET complete response rate for patients with unresected disease(12 weeks post Radiotherapy)