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临床试验/ACTRN12622001201763
ACTRN12622001201763尚未招募2 期

Efficacy of Treatment Targeting the Renin-Angiotensin System in Glioblastoma (TRAS-GB) Trial

Gillies McIndoe Research Institute0 个研究点目标入组 75 人开始时间: 2022年9月7日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
入组人数
75

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

入排标准

年龄范围
16 Years 至 80 Years(—)
性别
All

入选标准

  • Patients with histologically confirmed glioblastoma who have completed surgery (biopsy or debulking) and chemoradiotherapy or who have had radiotherapy alone, and have a good performance status with a Karnofsky score of at least 60.
  • Note the chemotherapy treatment is temozolomide (TMZ).

排除标准

  • 1.Are unable to provide informed consent
  • 2.Are unable to swallow tablets and capsules
  • 3.Have persistent platelet count of less than 100/µL
  • 4.Have not completed surgery and first cycle of TMZ concomitant with radiotherapy
  • 5.Require on-going treatment with medications that increase renin levels, such as calcium channel blockers and diuretics
  • 6.Are not motivated including those who are non-adherent, e.g., abuse alcohol
  • 7.Less than 16 years
  • 8.Older than 80 years
  • 9.On other studies or trials
  • 10.Have contraindications to any of the study treatments including asthma, systolic blood pressure (BP) less than or equal to 100mmHg, allergies to the trial medications, medications that interfere with the proposed treatments
  • 11.Have significant immune compromise including HIV infection, organ transplant patients on immunosuppression, chronic lymphocytic leukaemia
  • 12.Breastfeeding, pregnant or plan to be pregnant
  • 13.Have terminal organ failure:
  • a. Moderate or severe renal impairment (GFR less than 60mL/min)
  • b. Liver disease
  • c. Congestive heart failure/myocardial infarction within the last 6 months.
  • d. Cerebrovascular disease (CVA/TIA/hemiplegia, except mild dementia).
  • e. Moderate or severe peripheral vascular disease.
  • 14.Have a second cancer that is expected to impact on the results of this study.

研究者

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