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临床试验/DRKS00016613
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

发起方
Klinik für Radioonkologie, Klinikum rechts der Isar, TU München

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