Therapeutic Strategy Guided by PET-TDM for Patients With Grade I or Metastatic Seminoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 271
- 试验地点
- 1
- 主要终点
- Rate of patients without pathological fixation
研究概览
简要总结
The purpose of the study is to evaluate the ration of patients getting an lighten therapeutic strategy after 18F-fluoro-désoxyglucose positron emission tomography (PET-TDM) in grade I (cohort 1) or metastatic (cohort 2) seminoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 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
Cohort 1
-
PET-TDM
-
carboplatine: Dose (mg) = AUC x (GFR + 25)
-
GFR : glomérulaire filtration (ml/min)
-
AUC : area under curve (mg/ml x min)
干预措施: Carboplatin (Drug)
Cohort 2
-
PET-TDM
-
ETOPOSIDE (100 mg/m2 D1 to D5) and CISPLATINE (20 mg/m2 de D1 to D5)
-
carboplatine: Dose (mg) = AUC x (GFR + 25)
-
GFR : glomérulaire filtration (ml/min)
-
AUC : area under curve (mg/ml x min)
干预措施: Carboplatin (Drug)
Cohort 2
-
PET-TDM
-
ETOPOSIDE (100 mg/m2 D1 to D5) and CISPLATINE (20 mg/m2 de D1 to D5)
-
carboplatine: Dose (mg) = AUC x (GFR + 25)
-
GFR : glomérulaire filtration (ml/min)
-
AUC : area under curve (mg/ml x min)
干预措施: Etoposide (Drug)
Cohort 2
-
PET-TDM
-
ETOPOSIDE (100 mg/m2 D1 to D5) and CISPLATINE (20 mg/m2 de D1 to D5)
-
carboplatine: Dose (mg) = AUC x (GFR + 25)
-
GFR : glomérulaire filtration (ml/min)
-
AUC : area under curve (mg/ml x min)
干预措施: Cisplatin (Drug)
结局指标
主要结局
Rate of patients without pathological fixation
时间窗: Assessed at the time of inclusion or after 2 cycles of chemotherapy, up to 21 days
Rate of patients without pathological fixation at the time of the inclusion PET-TDM (cohort 1) or at the time of the PET-TDM following two cycles of chemotherapy (Etoposiede+Cisplatine) (cohort 2) and getting a lighten protocol
次要结局
- Progression Free Survival (PFS)(Assessed up to 5 years)
- Rate of patients without pathological fixation(Assessed at the time of inclusion or after 2 cycles of chemotherapy, up to 21 days)