ACTRN12614000531617进行中(未招募)1 期
Can reduced dose radiotherapy delivered in standard fractionation improve the therapeutic index for stereotactic treatment of juxtapapillary choroidal melanoma?
Peter MacCallum Cancer Centre0 个研究点目标入组 20 人开始时间: 2014年5月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 20
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- o limit 至 70 Years(—)
- 性别
- All
入选标准
- •1. Primary choroidal melanoma (small and medium sized)
- •- A clinical diagnosis of CM made by a suitably trained ophthalmologist is mandatory
- •- Features that define CM and must be present are a choroidal mass that is pigmented or hypopigmented AND EITHER:
- •a) Tumour height measured on beta ultrasound to be 2.5mm or greater OR
- •b) Documented growth of a lesion <2.5mm in height
- •2. Tumour height to 8mm or less
- •3. Tumour basal diameter 16mm or less
- •4. Visual acuity better than 6/60 ( or 0.1)
- •5. No evidence of metastatic disease on liver ultrasound
- •6. Age 70 or less
- •7. An ECOG performance status score of 0 - 2
- •8. Participants capable of childbearing are using adequate contraception
- •9. Available for follow up
- •10. Has provided written Informed Consent for participation in this trial
排除标准
- •1. Tumour involving the iris or ciliary body
- •2. Cytopathologic diagnosis is not uveal melanoma
- •3. Previous treatment to the affected eye with radiation, laser or thermotherapy
- •4. Non-malignant disease of the affected eye (that already has or could affect vision)
- •5. Known to have diabetes mellitus
- •6. Prior diagnosis of cancer that was:
- •- more than 5 years prior to current diagnosis with subsequent evidence of disease recurrence or clinical expectation of recurrence is greater than 10%
- •- within 5 years of current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma or carcinoma in situ of the cervix
- •7. Patients with clinical evidence of metastatic disease.
- •8. Women who are pregnant
- •9. Unable to give informed consent
研究者
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