NCT07601672尚未招募不适用
PRISTINE Trial: PRoton Beam Therapy In Seminoma - Toxicity INvestigation and Evaluation of Outcome
Istituto Clinico Humanitas0 个研究点目标入组 20 人开始时间: 2026年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
Stage II seminoma is a type of cancer that is usually highly curable and most often affects young men.
Radiotherapy is an effective treatment, but it can sometimes cause side effects in the long term and, rarely, increase the risk of developing another cancer later in life.For this reason, more targeted treatments are being explored, such as proton therapy (PBT). This type of radiotherapy uses protons to better focus the treatment on the tumor while reducing exposure to the surrounding healthy tissues.The goal is to treat the cancer effectively while minimizing side effects as much as possible.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Male gender
- •ECOG Performance status 0 - 1
- •Histologically confirmed diagnosis of testicular seminoma
- •Stage IIA - IIB disease with metastatic involvement limited to retroperitoneal lymph nodes measuring ≤3 cm in greatest diameter
- •Prior radical orchiectomy
- •Clinical indication for radiotherapy
- •Written informed consent provided
排除标准
- •Non-seminomatous germ cell tumor histology
- •Incomplete definitive surgical orchiectomy, including diagnostic biopsy alone
- •Prior or concurrent second malignancy other than non-melanoma skin cancer, unless disease free for a minimum of five years
- •Prior radiotherapy to the abdominal or pelvic region
- •Known severe, active co-morbidity
- •Inability or refusal to provide informed consent
研究者
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