2024-513778-23-00招募中3 期
A randomized double-blind placebo-controlled study with ASA treatment in colorectal cancer patients with mutations in the PI3K signaling pathway
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 31
- 主要终点
- • TTR at 3 years, in patients with tumors harboring PIK3CA mutations in exon 9 and 20
研究概览
简要总结
To determine whether adjuvant treatment with 160 mg Acetylsalicylic Acid (ASA) once daily for 3 years can improve Time To Recurrence (TTR) in patients with colorectal cancer with somatic alterations in the PIK3CA (exon 9 and 20), compared with placebo.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Tumor with somatic alterations in PIK3CA, PIK3R1 or PTEN
- •Colon cancer tumor stage II-III or rectal cancer tumor stage I-III
- •Patient between18-80 years (including)
- •Radical surgery according to surgeon and pathologist
- •Karnofsky performance status ≥60%
- •Platelets ≥ 100 x 109 / L
- •Clean Colonoscopy or Computed Tomography (CT) colon within 3 months preoperatively or postoperatively but before randomization
- •Patient able to swallow tablets
- •Patient able to understand and sign written informed consent
排除标准
- •Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome - Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- •Existing renal failure according to Investigator’s judgment. Renal failure with decreased creatinine clearance <60 should lead to consultation with a nephrologist.
- •Significant medical illness that would interfere with study participation
- •Pregnancy or breastfeeding females
- •Known allergy to NSAIDs or ASA
- •Current participation in another clinical trial that will be in conflict with the present study
- •Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study
- •Distant metastases
- •Other cancers (excluding colorectal cancer or other skin cancer than melanoma) within 3 years from screening
- •Known bleeding diathesis (such as hemophilia)
- •Concomitant antiplatelet therapy (eg clopidrogrel or ticlopidine) or anticoagulant therapy (warfarin or low molecular weight heparin). Post-operative treatment with low molecular weight heparin must be withdrawn before administration of study treatment
- •Active gastritis or peptic ulcer, or significant surgical post-op bleeding, within the previous three months assessed at screening and randomization
- •Ongoing regular use of corticosteroids, Nonsteroidal Anti-Inflammatory Drug (NSAID)
- •Uncontrolled hypertension according to Investigator’s judgment
- •Clinically significant liver impairment according to Investigators judgment
结局指标
主要结局
• TTR at 3 years, in patients with tumors harboring PIK3CA mutations in exon 9 and 20
• TTR at 3 years, in patients with tumors harboring PIK3CA mutations in exon 9 and 20
次要结局
未报告次要终点
研究者
Anna Martling
Scientific
Karolinska Institutet
研究点 (31)
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