DRKS00031749招募中2 期
PRIMETEST II – trial to test new predictors of recurrence in CS II A/B seminoma patients treated with primary robot-assisted retroperitoneal lymph node dissection - PRIMETEST II
niversitätsklinikum Düsseldorf0 个研究点目标入组 60 人开始时间: 2023年9月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- Male
入选标准
- •Histologically verified seminomatous testicular germ cell tumour
- •- and an iliac or retroperitoneal lymph node metastasis detected on contrast CT or MRI, which is classified as local or unilateral regionally.
- •- maximum extension of the lymph node metastasis (LK-M) singular or multiple with a maximum size of 5 cm in transverse CT diameter (UICC IIB)
排除标准
- •- LK-M with a transverse diameter >5 cm in the C (UICC IIC)
- •- Metastases other than LK-M (UICC III)
- •- The patient has received chemotherapy other than described above
- •- The patient has been treated with radiotherapy of the retroperitoneum
- •- The patient is in a reduced general condition or has a life-threatening illness
- •- The patient has a psychiatric illness
- •- Evidence of non-seminomatous germ cell tumour on RPLND histology
- •- Complete resection cannot be safely guaranteed due to previous surgery
- •- In the high risk group: contraindications to cisplatin, etoposide or bleomycin (severe hepatic insufficiency, severe renal insufficiency, severe pulmonary insufficiency, hypersensitivity, severe bone marrow depression, marked hearing impairment).
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