ISRCTN52658296已完成1 期
Short-course radiotherapy plus olaparib for newly diagnosed glioblastoma in patients unsuitable for radical chemoradiation: a randomised phase II clinical trial preceded by a lead-in phase I dose escalation study
HS Greater Glasgow and Clyde (UK)0 个研究点目标入组 140 人开始时间: 2014年6月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age 18 - 69: WHO performance status 2 at initial oncology consultation or performance status 0-1 but otherwise unsuitable for radical radiotherapy with concomitant and adjuvant temozolomide.
- •2. Age over 70: WHO performance status 0 or 1 at initial oncology consultation
- •3. Histologically confirmed diagnosis of glioblastoma
- •4. Life expectancy greater than 12 weeks
- •5. No previous radiotherapy or chemotherapy for primary or secondary CNS malignancy
- •6. Adequate haematological, hepatic and renal function defined as below:
- •Haemoglobin >/= 9.0 g/dL, absolute neutrophil count >/= 1.5 x 109/L, platelet count >/= 100 x 109/L, bilirubin 50 ml/min. If the creatinine clearance / glomerular filtration rate is less than 50 ml/min as calculated by the Cockroft-Gault/Wright formula, then the creatinine clearance / glomerular filtration rate should be measured by either a radio-isotope technique or by 24-hour urine collection.
- •7. Ability to provide written informed consent prior to participating in the trial and any trial related procedures being performed
- •8. Willingness to comply with scheduled visits, treatment plans and laboratory tests and other trial procedures
- •9. Ability to swallow oral tablets/capsules
排除标准
- •1. WHO performance status >2
- •2. Life expectancy less than 12 weeks
- •3. Active concurrent malignancy (except non-melanoma skin cancer or in situ carcinoma of the cervix). If history of prior malignancy, must be disease-free for >5 years.
- •4. Prior treatment for primary or secondary CNS malignancy
- •5. Confusion or altered mental state that would prohibit understanding and giving of informed consent
- •6. Concomitant treatment with medicines detailed in section 5.10 of protocol.
- •7. Female patients who are able to become pregnant (or already pregnant or lactating). However, those female patients who have a negative serum or urine pregnancy test before enrolment and agree to use two highly effective forms of contraception (oral, injected or implanted hormonal contraception and condom, have an intra-uterine device and condom, diaphragm with spermicidal gel and condom) effective at the first administration of either IMP, throughout the trial, and for six months afterwards, are considered eligible.
- •8. Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using one form of highly effective contraception [condom plus spermicide] effective at the first administration of IMP, throughout the trial, and for six months afterwards). Men with pregnant or lactating partners should be advised to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure to the foetus or neonate.
- •9. Administration of any investigational drug within 28 days of receiving the first dose of trial treatment.
研究者
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