DRKS00016613招募中1 期
eoadjuvant Radiotherapy (N-RT) for Intracerebal Metastases of Solid Tumors - NEPO_MUC
Klinik für Radioonkologie, Klinikum rechts der Isar, TU München0 个研究点目标入组 48 人开始时间: 2019年1月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
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
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one(—)
- 性别
- All
入选标准
- •Patients meeting all of the following criteria will be considered for admission to the trial:
- •Patients with 1-4 intracerebral metastases on contrast-enhanced MRI from solid tumors with known histology confirmed
- •One brain metastasis is = 3cm in size or
- •-Persisting neurologic symptoms or symptomatic epilepsy from brain metastases despite treatment with steroids.
- •-Tumor location close to eloquent brain areas therefore neurological symptoms can be expected without longtime steroidal medication.
- •-Patient is deciding to undergo surgical intervention, if resection and radiation therapy are equal treatment options or if the patient declines radiation therapy.
- •Age = 18 years of age
- •Karnofsky Performance Score = 70, ECOG = 1
- •For women with childbearing potential adequate contraception
- •Ability of subject to understand character and individual consequences of the clinical trial
- •Written informed consent (must be available before enrolment in the trial)
排除标准
- •Patients presenting with any of the following criteria will not be included in the trial:
- •Patients with unknown primary (CUP)
- •Tumor diameter of any single lesion exceeding 4 cm
- •Tumors causing severe neurological deficits or with mass effect requiring immediate surgical intervention
- •Previous radiotherapy to the brain
- •Known tumor of small cell histology, germ cell histology or lymphoma
- •Refusal of the patients to take part in the study
- •Patients who have not yet recovered from acute toxicities of prior therapies
- •Clinically active kidney-liver or cardiac disease
- •Known carcinoma < 5 years ago (excluding carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
研究者
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