NCT00828230终止2 期
Randomised, Double-blind, Placebo-controlled, Multicentre, Comparative Phase II Pilot Study on the Efficacy and Tolerability of an 8-week Rectal Treatment With 2 mg Budesonide or Placebo for the Prevention of Acute Radiation Proctitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 3
- 主要终点
- Proportion of patients developing radiation proctitis during treatment or need rescue medication
研究概览
简要总结
To proof the superiority of an 8-week rectal treatment with once-daily 2 mg budesonide versus placebo for the prevention of acute radiation proctitis, and to evaluate the occurrence of chronic radiation proctitis 1 year after start of radiation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent,
- •Men aged at least 18 years,
- •Patients with ECOG performance status <= 2 or Karnofsky Performance Status Scale >= 70%,
- •Estimated life expectancy more than 3 years,
- •Diagnosis of prostate carcinoma,
- •Indication for local RT in patients with prostatic cancer.
排除标准
- •Crohn's disease, indeterminate colitis, ulcerative colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis),
- •Severe or symptomatic ischaemic colitis at baseline,
- •Grade III internal haemorrhoids at baseline,
- •High risk patients needing extended radiation therapy,
- •Acute EORTC/RTOG lower GI toxicity score of >=1 at baseline,
- •Bacterial, amoebic, fungal, or viral infections of the gut,
- •Tuberculosis, hypertension, infection, diabetes mellitus (included familiarly predisposition), active peptic ulcer, osteoporosis, glaucoma, or cataract, if careful medical monitoring is not ensured,
- •Portal hypertension or liver cirrhosis,
- •Abnormal hepatic function (ALT, AST or AP > 2.5 x ULN),
- •Known intolerance/hypersensitivity/resistance to study drug or drugs of similar chemical structure or pharmacological profile, or to any of the other constituents of the study drug,
- •Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial
研究组 & 干预措施
1
Experimental
2mg rectal budesonide per day for 8 weeks
干预措施: budesonide (Drug)
2
Placebo Comparator
One application of placebo foam once daily for 8 weeks
干预措施: Placebo foam (Drug)
结局指标
主要结局
Proportion of patients developing radiation proctitis during treatment or need rescue medication
时间窗: within 8 weeks
次要结局
- Time to occurrence of acute radiation proctitis(During 8 weeks)
- Time to occurrence of chronic radiation proctitis(Within 1 year)
- Adverse Events (AEs)(During 8 weeks of treatment)
研究者
研究点 (3)
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