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临床试验/NCT04847284
NCT04847284招募中不适用

Intraoperative Radiotherapy in Patients With Brain Metastases

Parc de Salut Mar2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
25
试验地点
2
主要终点
Median local progression free survival (lPFS)

研究概览

简要总结

Intraoperative radiotherapy (IORT) is a new alternative for local radiotherapy with the advantages of dose escalation, reduced overall treatment time, and enhanced patient convenience, however the degree of efficacy is unknown, as well as and which is the most efficient dose.

The objective of this study is to evaluate the efficacy and safety of IORT in patients with surgical excision of brain metastases at a dose of 20 Gy is at least as effective and safe as other forms of radiation therapy in patients with resection of brain metastases.

详细描述

  1. INTRODUCTION

Brain metastases occur in roughly 30% of all cancer patients during their course of disease. Their incidence is believed to rise due to the aging population that develops more cancer per se, an increase in overall survival due to more effective extracranial therapies but with only few (novel) substances crossing the blood-brain barrier and more broadly available and more advanced imaging techniques.

Neurosurgical treatment remains a cornerstone in the management of brain metastasis, especially for lesions causing mass effects or neurological deficits or in case tissue is necessary to establish a diagnosis. As local recurrence rates are as high as 50-60% after surgical resection alone, adjuvant therapies to prevent such are necessary.

Whole brain radiotherapy (WBRT) does not influence survival but rather impairs neurocognitive functions and, as histologic in-depth exams of cavity borders showed that most brain metastases infiltrate only 0.3-1.2 mm into the surrounding healthy brain tissue, therefore treatment is to date usually confined to the cavity margin. Thus, the currently recommended standard of care is post-operative stereotactic radiosurgery (SRS) to the resection cavity. One of the drawbacks of this modality is the incidence of radionecrosis, especially in large tumor volumes. As an alternative to radiosurgery, hypofractionated local radiotherapy is also used, reducing the risk of radionecrosis in large volumes. There are no prospective randomized studies comparing both techniques.

The need to find a modality of radiotherapy that achieves al least the efficacy of radiosurgery or hypofractionated local radiotherapy, without the disadvantages thereof, makes IORT as a possible treatment alternative.

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

  • Age ≥ 18 years
  • Karnofsky Performance Status ≥ 70
  • Newly diagnosed cerebral or cerebellar lesion (contrast enhancing on a T1-weighted MRI scan) amenable to total resection with no dural attachment
  • Frozen section confirming a metastasis of an extracranial ( Central Nervous System i.e. non-CNS) tumor
  • Adequate distance to optic nerve(s), chiasm and brainstem (organs at risk for radiotherapy)
  • Adequate birth control

排除标准

  • Leptomeningeal spread and dural attachment (assessed pre- and intraoperatively)
  • Frozen section reveals primary CNS tumor, lymphoma, SCLC (Small-cell lung cancer) or germinoma
  • More than one brain metastasis
  • Psychiatric or social condition potentially interfering with compliance
  • Contraindication against anesthesia, surgery, MRI and/or contrast agents
  • Pregnant or breast-feeding women

结局指标

主要结局

Median local progression free survival (lPFS)

时间窗: 6 months from the date of surgery.

Recurrence within a 0.5 cm margin around the resection cavity, assessed by serial magnetic resonance imaging (MRI scans) and response assessment criteria in neuro-oncology (RANO)

Radiation-related acute neurotoxicity

时间窗: 3 months from the date of surgery.

Neurotoxicity related to radiotherapy evaluated according to the scale of the Common Terminology Criteria for Adverse Events (CTCAE) version 5. Score from 0 to 5, with 5 being the worst toxicity - Acute toxicity: cerebral edema

Radiation-related late neurotoxicity

时间窗: 6 months from the date of surgery.

Neurotoxicity related to radiotherapy evaluated according to the scale of the Common Terminology Criteria for Adverse Events (CTCAE) version 5. Score from 0 to 5, with 5 being the worst toxicity - Late toxicity: radionecrosis.

次要结局

  • Median overall survival (OS)(6 months from the date of surgery)
  • Median regional PFS (rPFS)(6 months from the date of surgery)
  • Global PFS (gPFS)(6 months from the date of surgery)

研究者

发起方
Parc de Salut Mar
申办方类型
Other
责任方
Sponsor

研究点 (2)

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