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临床试验/NCT03464305
NCT03464305进行中(未招募)3 期

A Phase III Double-blind Placebo-controlled Randomised Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients

University Hospital, Antwerp29 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2018年2月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
进行中(未招募)
入组人数
148
试验地点
29
主要终点
5 year overall survival

研究概览

简要总结

The purpose of this study is to determine whether acetylsalicylic acid is effective on the recurrence and survival of colon cancer patients.

详细描述

The purpose of this study is to determine the effect of 80mg acetylsalicylic acid (given orally once daily for 5 years) on 5 year overall survival (OS) for stage II and III colon cancer patients of 45 years of age and older. Preclinical, epidemiologic and clinical evidence suggest that acetylsalicylic acid use may reduce overall cancer risk and mortality in colon cancer patients. It is a phase III double blind placebo controlled, randomized trial of adjuvant low-dose acetylsalicylic acid in colon cancer patients. Patients will be stratified at randomization by centre, age (<70 and ≥70 years) chemotherapy use (any versus none) and disease stage.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 45 years and older with histologically confirmed adenocarcinoma of the colon
  • Patients must have TNM stage that is one of the following: pT3-4; N0-2 and M0, or pT1-2 and N1-2 (Union for International Cancer Control (UICC) stage II and III) (in case of >1 tumour: more advanced tumour is stage II or III)
  • Patients must have completed surgical resection (R0) (both laparoscopic and open surgery) within 12 weeks of randomization

排除标准

  • Patients with rectal cancer (defined as tumour within 15 cm from the anal verge)
  • Patients currently taking oral anti-coagulants or use of LMWH or use of DOACs
  • Patients currently taking (low-dose) acetylsalicylic acid or other anti-aggregantia for any reason
  • Patients with a history of bleeding disorders or active gastric or duodenal ulcers
  • Patients currently taking high dose systemic glucocorticoids (≥ 30 mg predniso(lo)n or equivalent)
  • Patients with (suspected) (non-) polyposis syndrome (FAP/AFAP, MAP, Lynch syndrome)
  • Patients with >100 polyps of the colon or a known hereditary syndrome of the colon in a first degree family member
  • Allergy or intolerance to salicylates
  • Patients with local or distant recurrent disease
  • Previous malignancies other than CIN or SCC with a disease free survival less than 5 years
  • Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

研究组 & 干预措施

Aspirin

Experimental

Patients treated with acetylsalicylic acid 80 mg once daily for 5 years. Patients will be stratified according to the admission of adjuvant chemotherapy.

干预措施: acetylsalicylic acid (Drug)

Placebo

Placebo Comparator

Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.

干预措施: Placebo (Drug)

结局指标

主要结局

5 year overall survival

时间窗: 5 years

The time to an event for OS is defined as the time interval between the date of randomisation and the date of death.

次要结局

  • Disease Free Survival(5 years)
  • Time to Treatment Failure(5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ethisch.comite@uza.be

Prof. dr. Marc Peeters, Diensthoofd Oncologie

University Hospital, Antwerp

研究点 (29)

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