跳至主要内容
临床试验/ACTRN12614000531617
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

发起方
Peter MacCallum Cancer Centre

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