ACTRN12614000513617进行中（未招募）3 期
ASCOLT Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers. An International, Multi-centre, Double Blind, Randomised Placebo Controlled Phase III Trial
Australasian Gastro-Intestinal Trial Group (AGITG)0 个研究点目标入组 476 人开始时间: 2014年5月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 476
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Male or female outpatient of at least 18 years of age or at least the country's legal age for adult consent
- •- Dukes C colon cancer, high risk Dukes B colon cancer, Dukes B rectal cancer or Dukes C rectal cancer
- •- Undergone complete resection of primary tumour
- •- Completed standard therapy (at least 3 months of chemotherapy with or without radiotherapy)
- •- Within 120 days of completion of standard therapy (surgery, chemotherapy with or without radiotherapy)
- •- ECOG performance status 0 to 2
- •- Satisfactory haematological or biochemical functions (tests should be carried out within 8 weeks prior to randomisation): Results of clinical investigations carried out within 8 weeks prior to randomisation can be used in place of the required screening investigations. Patients with mild laboratory abnormalities can be included at the discretion by the site principal investigator, and after approval by ASCOLT Trial Management GroupB-F57
- •- ANC greater than or equal to 1.0 x 109/L
- •- Platelets greater than or equal to 100 x 109/L
- •- Creatinine clearance greater than or equal to 30 mL/min
- •- Total bilirubin less than or equal to 2.0 x the upper limit
- •- AST & ALT less than or equal to 5 x the upper limit
- •- Completed the following investigations
- •- Colonoscopy (or CT colonogram) within 16 months prior
- •to randomization
- •- Imaging of abdomen (CT or CT colonogram or MRI or
- •PET or Ultrasound) within 16 months prior to
- •randomization
- •- Written informed consent
排除标准
- •- Pre-existing Familial adenomatous polyposis, inflammatory
- •bowel disease or ulcerative colitis
- •- Active gastritis or active peptic ulcer
- •- History of continuous daily use of PPI more than 1 year
- •prior to consent
- •- Gastrointestinal bleeding within the past one year
- •- Haemorrhagic diathesis (i.e. haemophilia)
- •- Uncontrolled hypertension (untreated systolic blood
- •pressure > 160 mmHg, or diastolic blood pressure > 95
- •- History of recent cancers (except for colorectal cancers,
- •non-melanoma skin cancers, basal cell carcinomas,
- •squamous cell carcinomas) in the past 5 years
- •- History of stroke, coronary arterial disease, angina, or
- •vascular disease
- •- Patients who are on current long term treatment (greater
- •than or equal to 4 consecutive weeks) with Aspirin, NSAID
- •or Cox-2 inhibitors
- •- History of erosive GERD or active erosive GERD on
- •gastroscopy.
- •- Patient on active current treatment of antiplatelet agents
- •(i.e. off-study Aspirin, clopidogrel, ticlopidine)
- •- Patient receiving active treatment of anticoagulants
- •(i.e. warfarin, low molecular weight heparins)
- •- Pregnant, lactating, or not using adequate contraception
- •- Patient having known allergy to NSAID or Aspirin
- •- Unexplained rise of CEA (i.e. smoker with elevated CEA will
- •not be excluded)
- •- Patient on other investigational drug
- •- Patients with HNPCC (Lynch Syndrome)
研究者
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