A Phase II Prospective Trial of Stereotactic Hypofractionated Radiation for Multiple (3-10) cerebral metastases including Neurological and Cognitive assessment

Icon Cancer Foundation0 个研究点目标入组 30 人开始时间: 2015年11月5日最近更新: 2024年1月22日

适应症

试验速览

暂无简介。

•Pathological evidence of a known non-haematological malignancy within 5 years of enrolment.
•Three to ten metastatic brain lesions or surgical cavities which correlate with the confirmed non-haematological malignancy.
•Total Planning Target Volume <15cc for single or three fraction treatment and <35cc for fractionated treatment (five fractions).
•Largest single Planning Target Volume of unresected disease <10cc
•Largest single Planning Target Volume of a resection cavity <15 cc
•Age >18years
•Participants 60 years of age or older must nominate a friend or relative whom will participate in the cognitive decline questionnaire sub-study.
•Must be sufficiently proficient in English to complete neuropsychology tests

•Cognitive impairment which may interfere with ability to participate in the neurocognitive assessments
•Untreated clinically significant hydrocephalus
•Haematological, Small cell, Germ Cell malignancy or unknown primary tumour
•Leptomeningeal disease
•Multiple new cranial nerve deficits in the absence of overt intracranial disease
•Prior cranial irradiation which would compromise safety if overlapped with protocol treatment
•Contra-indication for MRI and gadolinium contrast use:
•o Participants with a known risk of poor renal function must have an estimated Glomerular Filtration Rate >50 millilitres per minute
•o Known hypersensitivity to Gadolinium contrast
•o Non-MRI compatible VP shunt/surgical apparatus
•o Pacemaker/cardiac defibrillator not MRI compatible
•Contra-indications to steroid support (e.g. active peptic ulceration or previous steroid psychosis)

发起方