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临床试验/NCT03226483
NCT03226483Unknown不适用

Intraoperative Radiotherapy After the Resection of Brain Metastases - a Phase II Feasibility Study

Universitätsmedizin Mannheim2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年3月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Median local progression-free-survival

研究概览

简要总结

INTRAMET examines prospectively the effectiveness of an intraoperative radiotherapy immediate after the surgical resection of brain metastases. Patients won't receive further radiation therapy of the intraoperatively treated lesion.

详细描述

Brain metastases occur in up to 40% of all patients diagnosed with systemic cancer. Without adjuvant radiotherapy after resection of space occupying lesions local recurrence rates are high. That is why guidelines recommend a cavity boosting with x-rays. External beam radiotherapy can lower the risk of local recurrence but means longer hospitalization, prolongs the time to systemic salvage therapies and bears risks of radionecrosis and leucoencephalopathy with neurological and cognitive decline. A solution for this problem could be onetime intraoperative radiotherapy (IORT) with soft x-rays to sterilize the resection cavity, which may provide both: freedom from local recurrence fast track salvage therapy initiation.

INTRAMET is a single institution, open-label, prospective, phase 2 feasibility study for intraoperative radiotherapy immediately following resection of brain metastases. 50 adult patients with resectable not dural brain metastases should be treated in surgery after tumor resection with IORT with 20-30Gy prescribed to the margin of the resection cavity. The highest dose tolerable to surrounding risk structures (N. opticus, brainstem) should be used.

With this method, the investigators hope to show similar local control rates to postoperative external beam radiotherapy in line with guideline recommendations with less patient hospitalization and faster start of rescue therapies which could lead to a favorable overall outcome and less cognitive side effects.

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
All
接受健康志愿者

入选标准

  • Karnofsky Performance index ≥ 50%
  • MRI T1 Gadolinium enhancing non-dural resectable lesion
  • Informed consent
  • Adequate birth control
  • Frozen section confirms metastasis
  • Adequate distance to optic nerve and brainstem

排除标准

  • Dural lesions or meningeal carcinomatosis
  • Frozen section reveals glioma, lymphoma,small cell lung cancer or germinoma
  • Psychiatric or social condition interfering compliance
  • Contraindication against anesthesia, surgery, MRI and/or Gadolinium
  • Pregnant or breast-feeding women

结局指标

主要结局

Median local progression-free-survival

时间窗: 2 years

Rate of recurrence of the treated lesion in the brain

次要结局

  • Time to further therapy(6 month)
  • Patients cognitive performance(5 years)
  • Overall-survival(5 years)
  • Regional progression-free-survival(2 years)
  • Patients quality of life(5 years)
  • Intraoperative radiotherapy caused dose-limiting toxicities(6 month after intervention)
  • Global progression-free-survival(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefanie Brehmer

MD

Universitätsmedizin Mannheim

研究点 (2)

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